Gastroenteropancreatic Neuroendocrine Tumors
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).
Interventions
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available. * A somatostatin receptor scan with results in the previous 6 months prior to dosing day. * At least 1 lesion detected by the previous somatostatin receptor scan. * Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan. * Blood test results as follows (WBC: ≥ 3\*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN) * ECG: any abnormalities have to be clarified by a cardiologist. * Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older. * Calculated GFR ≥ 45 mL/min. * Negative pregnancy test in women capable of child-bearing.
Exclusion criteria
* Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS202. * History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids. * Presence of active infection at screening or history of serious infection within the previous 6 weeks. * Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C. * Any condition that precludes raised arms position for prolonged imaging purposes. * Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see below). * Therapeutic use of any somatostatin analog, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on Sandostatin® a wash-out phase of 2 days is required before the injection of the study drug. * Administration of another investigational medicinal product within 30 days prior to entry. * Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study. * Current \> grade 2 toxicity from previous standard or investigational therapies, per US-NCI Common Terminology Criteria for Adverse Events v4.0. * Pregnant or breast-feeding women. * History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. * Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product. * Current history of malignancy; patients with a secondary tumor in remission of \> 5 years can be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | From start of IP administration to end of the study visit (approximately 28 to 36 days) | An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202. |
| Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | From start of IP administration to end of the study visit (approximately 28 to 36 days) | Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 | Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point. |
| Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
| Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 | Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
| Mean SUVmax of RT for Session 2 | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 | The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
| Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 | The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
| Mean SUVmax of Malignant and Benign Lesions for Session 2 | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 | The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
| Percent Change in 3D-SUV-R of Malignant Lesions | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan. |
| Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | At 0.5, 1, 2, and 4 hour post-injection on Day 0 | For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used. |
| Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | At 0.5, 1, 2, and 4 hour post-injection on Day 0 | The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used. |
| Best Diagnostic Scan Assessment | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 | The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan. |
| The 3D-SUV-R of Malignant Lesions for Session 2 | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
| Number of Malignant and Benign Lesions Detected for Session 1 | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. |
Countries
Switzerland
Participant flow
Recruitment details
This open-label, micro-dosing study with 2 sequentially ascending single peptide doses was conducted in a single study center in Switzerland between 23 June 2014 and 14 January 2015.
Pre-assignment details
A total of 12 participants with histologically confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP NET) and a previously performed somatostatin receptor scan were treated in this study. Each participant underwent a screening visit within 28 days prior to receiving the study's investigational product (IP).
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 14.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.
Time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)
Population: The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | Any AE | 6 Participants |
| All Participants | Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | SAEs | 0 Participants |
| All Participants | Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | ADRs | 5 Participants |
Primary
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication
Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.
Time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)
Population: The SAF included all participants of the FAS who received the investigational product, regardless of any protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Laboratory parameters abnormalities | 8 Participants |
| All Participants | Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Vital sign abnormalities | 7 Participants |
| All Participants | Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | 12-Lead ECG abnormalities | 1 Participants |
| All Participants | Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Physical examination abnormalities | 9 Participants |
| All Participants | Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Concomitant medications required | 12 Participants |
Secondary
Best Diagnostic Scan Assessment
The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants | Best Diagnostic Scan Assessment | At 0.5 hour | 4.0 score on a scale |
| All Participants | Best Diagnostic Scan Assessment | At 1 hour | 5.0 score on a scale |
| All Participants | Best Diagnostic Scan Assessment | At 2 hour | 4.5 score on a scale |
| All Participants | Best Diagnostic Scan Assessment | At 4 hour | 2.0 score on a scale |
| ITT Population (Day 0) | Best Diagnostic Scan Assessment | At 1 hour | 5.0 score on a scale |
Secondary
Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1
At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Thyroid gland | 3.768 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Liver | 12.135 SUVmax | Standard Deviation 4.466 |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Lymph node | 15.192 SUVmax | Standard Deviation 7.4318 |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Peritoneum | 6.579 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Pancreas | 14.086 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Small bowel | 8.264 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Bone | 4.394 SUVmax | Standard Deviation 0.9396 |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Small bowel | 14.049 SUVmax | Standard Deviation 0.2124 |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Lymph node | 3.093 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Mamma | 2.353 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Mediastinum | 2.242 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Spleen | 16.343 SUVmax | — |
| All Participants | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Stomach | 6.713 SUVmax | — |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Stomach | 7.630 SUVmax | — |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Pancreas | 8.693 SUVmax | — |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Spleen | 15.997 SUVmax | — |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Lung | 3.410 SUVmax | — |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Liver | 10.468 SUVmax | Standard Deviation 4.797 |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Bone | 4.153 SUVmax | Standard Deviation 2.027 |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Lymph node | 16.289 SUVmax | Standard Deviation 12.0091 |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Peritoneum | 6.740 SUVmax | — |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Small bowel | 11.140 SUVmax | Standard Deviation 7.9828 |
| ITT Population (Day 0) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Mamma | 2.907 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Spleen | 14.308 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Small bowel | 9.156 SUVmax | Standard Deviation 1.0674 |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Peritoneum | 9.504 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Pancreas | 6.659 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Small bowel | 4.990 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Stomach | 5.305 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Liver | 8.458 SUVmax | Standard Deviation 3.484 |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Lymph node | 14.602 SUVmax | Standard Deviation 10.9725 |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Lung | 3.131 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Benign: Mamma | 2.538 SUVmax | — |
| ITT Population (Day 21) | Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | Malignant: Bone | 4.455 SUVmax | Standard Deviation 0.2425 |
Comparison: Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.25Wilcoxon signed rank test
Comparison: Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.004Wilcoxon signed rank test
Comparison: Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.688Wilcoxon signed rank test
Comparison: Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.578Wilcoxon signed rank test
Secondary
Mean SUVmax of Malignant and Benign Lesions for Session 2
The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Benign: Pancreas: At 4 hour | 5.759 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Bone: At 2 hour | 4.601 SUVmax | Standard Deviation 1.3164 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Peritoneum: At 0.5 hour | 3.293 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Peritoneum: At 1 hour | 6.740 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Small bowel: At 1 hour | 11.207 SUVmax | Standard Deviation 4.5367 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Peritoneum: At 4 hour | 7.216 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Small bowel: At 0.5 hour | 9.474 SUVmax | Standard Deviation 5.8641 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Small bowel: At 2 hour | 9.075 SUVmax | Standard Deviation 4.9059 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Small bowel: At 4 hour | 14.695 SUVmax | Standard Deviation 6.9926 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Benign: Pancreas: At 0.5 hour | 8.561 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Benign: Pancreas: At 2 hour | 8.734 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Benign: Pancreas: At 1 hour | 8.512 SUVmax | — |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Bone: At 0.5 hour | 4.938 SUVmax | Standard Deviation 1.1179 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Bone: At 1 hour | 4.153 SUVmax | Standard Deviation 2.027 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Bone: At 4 hour | 4.564 SUVmax | Standard Deviation 1.0832 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Liver: At 0.5 hour | 10.086 SUVmax | Standard Deviation 5.0229 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Liver: At 1 hour | 11.485 SUVmax | Standard Deviation 6.3691 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Liver: At 2 hour | 9.897 SUVmax | Standard Deviation 4.3537 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Liver: At 4 hour | 12.482 SUVmax | Standard Deviation 5.941 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Lymph node: At 0.5 hour | 14.581 SUVmax | Standard Deviation 9.7609 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Lymph node: At 1 hour | 17.044 SUVmax | Standard Deviation 11.6224 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Lymph node: At 2 hour | 18.166 SUVmax | Standard Deviation 10.694 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Lymph node: At 4 hour | 17.985 SUVmax | Standard Deviation 13.5368 |
| All Participants | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Peritoneum: At 2 hour | 7.484 SUVmax | — |
| ITT Population (Day 0) | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Small bowel: At 1 hour | 7.440 SUVmax | Standard Deviation 2.8588 |
| ITT Population (Day 0) | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Lymph node: At 1 hour | 15.836 SUVmax | Standard Deviation 10.9868 |
| ITT Population (Day 0) | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Benign: Pancreas: At 1 hour | 6.659 SUVmax | — |
| ITT Population (Day 0) | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Peritoneum: At 1 hour | 9.504 SUVmax | — |
| ITT Population (Day 0) | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Liver: At 1 hour | 9.037 SUVmax | Standard Deviation 3.9033 |
| ITT Population (Day 0) | Mean SUVmax of Malignant and Benign Lesions for Session 2 | Malignant: Bone: At 1 hour | 4.455 SUVmax | Standard Deviation 0.2425 |
Comparison: Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.027Wilcoxon signed rank test
Comparison: Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.219Wilcoxon signed rank test
Secondary
Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1
Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Bone | 0.610 SUVmax | Standard Deviation 0.1801 |
| All Participants | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Small bowel | 4.180 SUVmax | Standard Deviation 0.7893 |
| All Participants | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Muscle | 1.020 SUVmax | Standard Deviation 0.3141 |
| All Participants | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Liver | 6.801 SUVmax | Standard Deviation 1.9676 |
| All Participants | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Peritoneum | 0.776 SUVmax | — |
| All Participants | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Lymph node | 2.229 SUVmax | Standard Deviation 1.2017 |
| ITT Population (Day 0) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Bone | 0.739 SUVmax | Standard Deviation 0.178 |
| ITT Population (Day 0) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Lymph node | 1.870 SUVmax | Standard Deviation 0.6967 |
| ITT Population (Day 0) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Peritoneum | 0.927 SUVmax | — |
| ITT Population (Day 0) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Small bowel | 2.080 SUVmax | Standard Deviation 0.5162 |
| ITT Population (Day 0) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Muscle | 0.883 SUVmax | Standard Deviation 0.253 |
| ITT Population (Day 0) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Liver | 3.642 SUVmax | Standard Deviation 1.6381 |
| ITT Population (Day 21) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Muscle | 0.896 SUVmax | Standard Deviation 0.1812 |
| ITT Population (Day 21) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Small bowel | 1.707 SUVmax | Standard Deviation 0.0636 |
| ITT Population (Day 21) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Lymph node | 2.368 SUVmax | Standard Deviation 1.7112 |
| ITT Population (Day 21) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Liver | 2.959 SUVmax | Standard Deviation 0.8089 |
| ITT Population (Day 21) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Bone | 0.636 SUVmax | Standard Deviation 0.1207 |
| ITT Population (Day 21) | Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Peritoneum | 1.401 SUVmax | — |
Comparison: Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.064Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.339Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.001Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.297Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 1Wilcoxon signed rank test
Secondary
Mean SUVmax of RT for Session 2
The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean SUVmax of RT for Session 2 | Small bowel: At 4 hour | 3.177 SUVmax | Standard Deviation 0.7174 |
| All Participants | Mean SUVmax of RT for Session 2 | Muscle: At 1 hour | 0.932 SUVmax | Standard Deviation 0.2386 |
| All Participants | Mean SUVmax of RT for Session 2 | Peritoneum: At 2 hour | 0.856 SUVmax | — |
| All Participants | Mean SUVmax of RT for Session 2 | Peritoneum: At 4 hour | 1.501 SUVmax | — |
| All Participants | Mean SUVmax of RT for Session 2 | Small bowel: At 0.5 hour | 2.519 SUVmax | Standard Deviation 0.2743 |
| All Participants | Mean SUVmax of RT for Session 2 | Small bowel: At 1 hour | 2.571 SUVmax | Standard Deviation 1.0644 |
| All Participants | Mean SUVmax of RT for Session 2 | Small bowel: At 2 hour | 2.124 SUVmax | Standard Deviation 0.7382 |
| All Participants | Mean SUVmax of RT for Session 2 | Muscle: At 0.5 hour | 0.923 SUVmax | Standard Deviation 0.226 |
| All Participants | Mean SUVmax of RT for Session 2 | Muscle: At 2 hour | 1.127 SUVmax | Standard Deviation 0.3343 |
| All Participants | Mean SUVmax of RT for Session 2 | Lymph node: At 0.5 hour | 1.723 SUVmax | Standard Deviation 0.9118 |
| All Participants | Mean SUVmax of RT for Session 2 | Muscle: At 4 hour | 2.013 SUVmax | Standard Deviation 0.6884 |
| All Participants | Mean SUVmax of RT for Session 2 | Bone: At 0.5 hour | 0.573 SUVmax | Standard Deviation 0.3418 |
| All Participants | Mean SUVmax of RT for Session 2 | Bone: At 1 hour | 0.605 SUVmax | Standard Deviation 0.3681 |
| All Participants | Mean SUVmax of RT for Session 2 | Bone: At 2 hour | 0.731 SUVmax | Standard Deviation 0.055 |
| All Participants | Mean SUVmax of RT for Session 2 | Bone: At 4 hour | 2.138 SUVmax | Standard Deviation 0.7022 |
| All Participants | Mean SUVmax of RT for Session 2 | Liver: At 0.5 hour | 4.201 SUVmax | Standard Deviation 1.3697 |
| All Participants | Mean SUVmax of RT for Session 2 | Liver: At 1 hour | 4.040 SUVmax | Standard Deviation 1.5213 |
| All Participants | Mean SUVmax of RT for Session 2 | Liver: At 2 hour | 4.103 SUVmax | Standard Deviation 1.2389 |
| All Participants | Mean SUVmax of RT for Session 2 | Liver: At 4 hour | 6.101 SUVmax | Standard Deviation 2.7773 |
| All Participants | Mean SUVmax of RT for Session 2 | Lymph node: At 1 hour | 2.049 SUVmax | Standard Deviation 0.7805 |
| All Participants | Mean SUVmax of RT for Session 2 | Lymph node: At 2 hour | 2.467 SUVmax | Standard Deviation 1.3033 |
| All Participants | Mean SUVmax of RT for Session 2 | Lymph node: At 4 hour | 1.989 SUVmax | Standard Deviation 0.6904 |
| All Participants | Mean SUVmax of RT for Session 2 | Peritoneum: At 0.5 hour | 1.864 SUVmax | — |
| All Participants | Mean SUVmax of RT for Session 2 | Peritoneum: At 1 hour | 1.038 SUVmax | — |
| ITT Population (Day 0) | Mean SUVmax of RT for Session 2 | Muscle: At 1 hour | 0.976 SUVmax | Standard Deviation 0.2012 |
| ITT Population (Day 0) | Mean SUVmax of RT for Session 2 | Bone: At 1 hour | 0.765 SUVmax | Standard Deviation 0.1409 |
| ITT Population (Day 0) | Mean SUVmax of RT for Session 2 | Liver: At 1 hour | 3.480 SUVmax | Standard Deviation 1.1863 |
| ITT Population (Day 0) | Mean SUVmax of RT for Session 2 | Lymph node: At 1 hour | 1.757 SUVmax | Standard Deviation 1.1486 |
| ITT Population (Day 0) | Mean SUVmax of RT for Session 2 | Peritoneum: At 1 hour | 1.163 SUVmax | — |
| ITT Population (Day 0) | Mean SUVmax of RT for Session 2 | Small bowel: At 1 hour | 1.608 SUVmax | Standard Deviation 0.3677 |
Comparison: Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.47Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.233Wilcoxon signed rank test
Comparison: Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.375Wilcoxon signed rank test
Secondary
Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1
The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Liver (RT: Muscle) | 13.434 ratio | Standard Deviation 7.3703 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Small bowel (RT: Muscle) | 15.353 ratio | Standard Deviation 7.143 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Lymph node (RT: Lymph node) | 9.548 ratio | Standard Deviation 7.1592 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Lymph node (RT: Muscle) | 15.110 ratio | Standard Deviation 7.4282 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Peritoneum (RT: Muscle) | 8.366 ratio | — |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Peritoneum (RT: Peritoneum) | 8.475 ratio | — |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Bone (RT: Bone) | 7.296 ratio | Standard Deviation 0.6136 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Small bowel (RT: Small bowel) | 3.427 ratio | Standard Deviation 0.6978 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Bone (RT: Muscle) | 5.227 ratio | Standard Deviation 1.7044 |
| All Participants | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Liver (RT: Liver) | 2.066 ratio | Standard Deviation 0.9163 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Liver (RT: Muscle) | 12.605 ratio | Standard Deviation 7.9383 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Bone (RT: Bone) | 6.125 ratio | Standard Deviation 4.2161 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Liver (RT: Liver) | 3.234 ratio | Standard Deviation 1.813 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Lymph node (RT: Lymph node) | 9.320 ratio | Standard Deviation 5.259 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Small bowel (RT: Muscle) | 12.585 ratio | Standard Deviation 6.1981 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Peritoneum (RT: Muscle) | 9.170 ratio | — |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Lymph node (RT: Muscle) | 19.861 ratio | Standard Deviation 16.0492 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Bone (RT: Muscle) | 6.091 ratio | Standard Deviation 2.1353 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Small bowel (RT: Small bowel) | 6.017 ratio | Standard Deviation 5.3303 |
| ITT Population (Day 0) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Peritoneum (RT: Peritoneum) | 7.268 ratio | — |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Bone (RT: Muscle) | 5.868 ratio | Standard Deviation 0.4515 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Peritoneum (RT: Muscle) | 11.399 ratio | — |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Small bowel (RT: Small bowel) | 5.355 ratio | Standard Deviation 0.4256 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Small bowel (RT: Muscle) | 11.352 ratio | Standard Deviation 2.5753 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Bone (RT: Bone) | 7.167 ratio | Standard Deviation 1.7409 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Peritoneum (RT: Peritoneum) | 6.783 ratio | — |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Liver (RT: Liver) | 3.215 ratio | Standard Deviation 1.816 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Liver (RT: Muscle) | 10.318 ratio | Standard Deviation 5.7811 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Lymph node (RT: Lymph node) | 11.034 ratio | Standard Deviation 13.3938 |
| ITT Population (Day 21) | Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | Lymph node (RT: Muscle) | 18.349 ratio | Standard Deviation 15.9027 |
Comparison: Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.004Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.004Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.426Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.098Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.813Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.813Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.297Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.469Wilcoxon signed rank test
Secondary
Number of Malignant and Benign Lesions Detected for Session 1
At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Population: The Intention-to-Treat (ITT) set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Mamma | 2.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Mediastinum | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Total | 3.0 lesion | Standard Deviation 1.83 |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Pancreas | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Lymph node | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Lymph node | 2.5 lesion | Standard Deviation 2.56 |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Spleen | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Total | 9.3 lesion | Standard Deviation 10.49 |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Bone | 1.0 lesion | Standard Deviation 0 |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Stomach | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Small bowel | 1.0 lesion | Standard Deviation 0 |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Small bowel | 4.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Thyroid gland | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Liver | 8.6 lesion | Standard Deviation 10.62 |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Peritoneum | 1.0 lesion | — |
| All Participants | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Lung | 0.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Mamma | 2.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Small bowel | 2.0 lesion | Standard Deviation 1.41 |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Total | 1.8 lesion | Standard Deviation 2.87 |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Lymph node | 0.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Lung | 2.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Liver | 17.4 lesion | Standard Deviation 17.98 |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Small bowel | 0.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Mediastinum | 0.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Bone | 1.0 lesion | Standard Deviation 0 |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Pancreas | 1.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Spleen | 1.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Lymph node | 2.9 lesion | Standard Deviation 2.1 |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Stomach | 1.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Total | 17.0 lesion | Standard Deviation 17.31 |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Thyroid gland | 0.0 lesion | — |
| ITT Population (Day 0) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Peritoneum | 1.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Small bowel | 4.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Total | 20.1 lesion | Standard Deviation 20.58 |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Bone | 1.0 lesion | Standard Deviation 0 |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Liver | 21.7 lesion | Standard Deviation 20.86 |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Lymph node | 2.5 lesion | Standard Deviation 2.27 |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Peritoneum | 1.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Lymph node | 0.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Mediastinum | 0.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Pancreas | 1.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Spleen | 1.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Stomach | 1.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Thyroid gland | 0.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Mamma | 2.0 lesion | — |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Malignant: Small bowel | 1.5 lesion | Standard Deviation 0.71 |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Total | 3.0 lesion | Standard Deviation 3.16 |
| ITT Population (Day 21) | Number of Malignant and Benign Lesions Detected for Session 1 | Benign: Lung | 3.0 lesion | — |
Comparison: Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.016Wilcoxon signed rank test
Comparison: Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.004Wilcoxon signed rank test
Comparison: Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.012Wilcoxon signed rank test
Comparison: Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.004Wilcoxon signed rank test
Comparison: Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.p-value: 0.5Wilcoxon signed rank test
Comparison: Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 1Wilcoxon signed rank test
Secondary
Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value
The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Bone) | At 0.5 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Bone) | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Bone) | At 2 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Bone) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Muscle) | At 0.5 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Muscle) | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Muscle) | At 2 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Bone (RT: Muscle) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Liver) | At 0.5 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Liver) | At 1 hour | 4 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Liver) | At 2 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Liver) | At 4 hour | 3 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Muscle) | At 0.5 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Muscle) | At 1 hour | 5 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Muscle) | At 2 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Liver (RT: Muscle) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Lymph node) | At 0.5 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Lymph node) | At 1 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Lymph node) | At 2 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Lymph node) | At 4 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Muscle) | At 0.5 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Muscle) | At 1 hour | 5 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Muscle) | At 2 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Lymph node (RT: Muscle) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Peritoneum) | At 0.5 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Peritoneum) | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Peritoneum) | At 2 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Peritoneum) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Muscle) | At 0.5 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Muscle) | At 1 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Muscle) | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Peritoneum (RT: Muscle) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Small bowel) | At 0.5 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Small bowel) | At 1 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Small bowel) | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Small bowel) | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Muscle) | At 0.5 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Muscle) | At 1 hour | 3 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Muscle) | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | Small bowel (RT: Muscle) | At 4 hour | 0 Participants |
Secondary
Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location
For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Total | At 0.5 hour | 5 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Total | At 1 hour | 3 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Total | At 2 hour | 4 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Total | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Bone | At 0.5 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Bone | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Bone | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Bone | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Liver | At 0.5 hour | 2 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Liver | At 1 hour | 3 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Liver | At 2 hour | 4 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Liver | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Lymph node | At 0.5 hour | 7 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Lymph node | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Lymph node | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Lymph node | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Pancreas | At 0.5 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Pancreas | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Pancreas | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Pancreas | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Peritoneum | At 0.5 hour | 1 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Peritoneum | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Peritoneum | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Peritoneum | At 4 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Small bowel | At 0.5 hour | 3 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Small bowel | At 1 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Small bowel | At 2 hour | 0 Participants |
| All Participants | Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | Small bowel | At 4 hour | 0 Participants |
Secondary
Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding
Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Thyroid gland: At 4 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Total: At 1 hour | 100 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Mamma: At 4 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Peritoneum: At 2 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Peritoneum: At 4 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Small bowel: At 0.5 hour | 25.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Small bowel: At 1 hour | 25.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Small bowel: At 2 hour | 25.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Small bowel: At 4 hour | 16.7 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Thyroid gland: At 0.5 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Thyroid gland: At 2 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Total: At 0.5 hour | 100 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Liver: At 1 hour | 75.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Pancreas: At 0.5 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Pancreas: At 1 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Pancreas: At 2 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Pancreas: At 4 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Peritoneum: At 0.5 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Peritoneum: At 1 hour | 8.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Thyroid gland: At 1 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Total: At 2 hour | 100 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Total: At 4 hour | 100 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Bone: At 0.5 hour | 16.7 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Bone: At 1 hour | 16.7 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Bone: At 2 hour | 16.7 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Bone: At 4 hour | 16.7 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Liver: At 0.5 hour | 75.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Liver: At 2 hour | 75.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Liver: At 4 hour | 75.0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lung: At 0.5 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lung: At 1 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lung: At 2 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lung: At 4 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lymph node: At 0.5 hour | 58.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lymph node: At 1 hour | 58.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lymph node: At 2 hour | 58.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lymph node: At 4 hour | 58.3 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Mamma: At 0.5 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Mamma: At 1 hour | 0 percentage of participants |
| All Participants | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Mamma: At 2 hour | 0 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Total: At 1 hour | 100 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Small bowel: At 1 hour | 25.0 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Thyroid gland: At 1 hour | 0 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lymph node: At 1 hour | 58.3 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Pancreas: At 1 hour | 8.3 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Mamma: At 1 hour | 0 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Liver: At 1 hour | 75.0 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Lung: At 1 hour | 0 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Bone: At 1 hour | 16.7 percentage of participants |
| ITT Population (Day 0) | Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Peritoneum: At 1 hour | 8.3 percentage of participants |
Secondary
Percent Change in 3D-SUV-R of Malignant Lesions
The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan.
Time frame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Lymph node (RT: Lymph node) | 56.044 percent change | Standard Deviation 94.8768 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Bone (RT: Bone) | -13.315 percent change | Standard Deviation 65.0759 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Peritoneum (RT: Peritoneum) | -14.239 percent change | — |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Liver (RT: Liver) | 51.938 percent change | Standard Deviation 33.2221 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Peritoneum (RT: Muscle) | 9.619 percent change | — |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Lymph node (RT: Muscle) | 46.569 percent change | Standard Deviation 61.4515 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Small bowel (RT: Small bowel) | 63.131 percent change | Standard Deviation 122.3379 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Liver (RT: Muscle) | -5.165 percent change | Standard Deviation 32.3975 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Small bowel (RT: Muscle) | 2.447 percent change | Standard Deviation 88.0324 |
| All Participants | Percent Change in 3D-SUV-R of Malignant Lesions | Bone (RT: Muscle) | 16.042 percent change | Standard Deviation 3.0132 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Small bowel (RT: Muscle) | -12.716 percent change | Standard Deviation 57.3817 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Bone (RT: Bone) | -0.418 percent change | Standard Deviation 32.2352 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Bone (RT: Muscle) | 20.052 percent change | Standard Deviation 47.7825 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Liver (RT: Liver) | 50.766 percent change | Standard Deviation 25.4179 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Liver (RT: Muscle) | -19.838 percent change | Standard Deviation 37.5669 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Lymph node (RT: Muscle) | 36.864 percent change | Standard Deviation 79.3287 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Peritoneum (RT: Peritoneum) | -19.962 percent change | — |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Peritoneum (RT: Muscle) | 36.256 percent change | — |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Small bowel (RT: Small bowel) | 58.296 percent change | Standard Deviation 19.8143 |
| ITT Population (Day 0) | Percent Change in 3D-SUV-R of Malignant Lesions | Lymph node (RT: Lymph node) | 38.530 percent change | Standard Deviation 117.3139 |
Secondary
The 3D-SUV-R of Malignant Lesions for Session 2
The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Population: The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Muscle): At 4 hour | 6.686 ratio | Standard Deviation 1.5046 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Peritoneum): At 4 hour | 4.809 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Bone): At 0.5 hour | 11.191 ratio | Standard Deviation 8.6266 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Bone): At 1 hour | 9.679 ratio | Standard Deviation 9.2426 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Muscle): At 4 hour | 2.626 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Small bowel): At 0.5 hour | 3.759 ratio | Standard Deviation 2.169 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Small bowel): At 1 hour | 5.644 ratio | Standard Deviation 4.9619 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Small bowel): At 2 hour | 4.363 ratio | Standard Deviation 2.5614 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Muscle): At 1 hour | 11.787 ratio | Standard Deviation 5.809 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Small bowel): At 4 hour | 4.047 ratio | Standard Deviation 1.6457 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Muscle): At 0.5 hour | 9.404 ratio | Standard Deviation 5.282 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Peritoneum): At 2 hour | 8.747 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Muscle): At 2 hour | 7.267 ratio | Standard Deviation 3.8995 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Lymph node): At 2 hour | 9.722 ratio | Standard Deviation 7.1821 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Bone): At 2 hour | 6.243 ratio | Standard Deviation 1.3313 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Bone): At 4 hour | 2.169 ratio | Standard Deviation 0.2056 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Muscle): At 0.5 hour | 6.716 ratio | Standard Deviation 1.4013 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Muscle): At 1 hour | 5.528 ratio | Standard Deviation 2.1555 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Muscle): At 2 hour | 5.311 ratio | Standard Deviation 2.1658 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Muscle): At 4 hour | 2.331 ratio | Standard Deviation 0.5535 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Liver): At 0.5 hour | 2.547 ratio | Standard Deviation 1.5468 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Liver): At 1 hour | 3.071 ratio | Standard Deviation 2.3858 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Liver): At 2 hour | 2.430 ratio | Standard Deviation 0.9559 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Liver): At 4 hour | 2.038 ratio | Standard Deviation 0.6822 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Muscle): At 0.5 hour | 11.534 ratio | Standard Deviation 8.0671 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Muscle): At 1 hour | 13.231 ratio | Standard Deviation 10.4892 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Muscle): At 2 hour | 9.383 ratio | Standard Deviation 6.1356 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Muscle): At 4 hour | 6.974 ratio | Standard Deviation 6.4729 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Lymph node): At 0.5 hour | 13.448 ratio | Standard Deviation 12.3973 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Lymph node): At 1 hour | 10.109 ratio | Standard Deviation 7.3722 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Lymph node): At 4 hour | 9.889 ratio | Standard Deviation 5.8842 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Muscle): At 0.5 hour | 16.362 ratio | Standard Deviation 9.1362 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Muscle): At 1 hour | 20.434 ratio | Standard Deviation 13.606 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Muscle): At 2 hour | 16.107 ratio | Standard Deviation 9.5271 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Muscle): At 4 hour | 8.619 ratio | Standard Deviation 3.7444 |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Peritoneum): At 0.5 hour | 1.767 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Peritoneum): At 1 hour | 6.494 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Muscle): At 0.5 hour | 4.431 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Muscle): At 1 hour | 8.508 ratio | — |
| All Participants | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Muscle): At 2 hour | 7.709 ratio | — |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Bone): At 1 hour | 5.891 ratio | Standard Deviation 0.7682 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Liver): At 1 hour | 2.514 ratio | Standard Deviation 0.6087 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Muscle): At 1 hour | 18.562 ratio | Standard Deviation 15.1302 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Peritoneum): At 1 hour | 8.173 ratio | — |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Lymph node (RT: Lymph node): At 1 hour | 14.166 ratio | Standard Deviation 13.4067 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Bone (RT: Muscle): At 1 hour | 5.530 ratio | Standard Deviation 0.8944 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Small bowel): At 1 hour | 4.956 ratio | Standard Deviation 2.8311 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Liver (RT: Muscle): At 1 hour | 9.653 ratio | Standard Deviation 5.1879 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Small bowel (RT: Muscle): At 1 hour | 7.678 ratio | Standard Deviation 3.9023 |
| ITT Population (Day 0) | The 3D-SUV-R of Malignant Lesions for Session 2 | Peritoneum (RT: Muscle): At 1 hour | 10.060 ratio | — |
Comparison: Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.91Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.039Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.375Wilcoxon signed rank test
Comparison: Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.p-value: 0.219Wilcoxon signed rank test