Breast Cancer, Head and Neck Cancer, High Grade Gliomas, Lung Cancer, Renal Cell Carcinoma, Sarcoma, Solid Tumors
Conditions
Brief summary
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.
Interventions
DRUGFluciclatide Injection
Fluciclatide Injection (AH111585 (18F) Injection)
Sponsors
BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)
Quintiles, Inc.
i3 Statprobe
GE Healthcare
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
* The subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, breast and H&N cancers. * The subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first \[18F\]AH111585 PET scan. * The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care.
Exclusion criteria
* The subject has known hyper- or hypo-coagulation syndromes. * The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first \[18F\]AH111585 PET scan. * The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second \[18F\]AH111585 PET scans. * The subject is scheduled to undergo biopsy for the target tumour between the first and second \[18F\]AH111585 PET scans. * The subject has intra-hepatic tumour(s) only. * For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first \[18F\]AH111585 PET scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration. | Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Up to 8 weeks post contrast administration. | Safety was monitored throughout the duration of the subject's participation. |
Countries
United States
Participant flow
Recruitment details
70 Subjects started and enrolled in this study. 41 Subjects completed this study and 29 did not complete this study.
Pre-assignment details
Due to the number of subjects that did not complete this study, additional subjects were enrolled bring to total enrolment to 70 subjects.
Participants by arm
| Arm | Count |
|---|---|
| 1 Fluciclatide Injection Fluciclatide Injection (AH111585 (18F) Injection) | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 29 |
Baseline characteristics
| Characteristic | 1 Fluciclatide Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 12.71 |
| Region of Enrollment India | 18 participants |
| Region of Enrollment Korea, Republic of | 8 participants |
| Region of Enrollment Sweden | 4 participants |
| Region of Enrollment United Kingdom | 19 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 49 |
| serious Total, serious adverse events | 7 / 49 |
Outcome results
Primary
Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Time frame: Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.
Population: Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imaging Session 1 | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 65 Minute Post Injection | 4.584 Standardized Uptake Value | Standard Deviation 2.3266 |
| Imaging Session 1 | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 40 Minute Post Injection | 4.536 Standardized Uptake Value | Standard Deviation 2.2113 |
| Imaging Session 1 | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 90 Minute Post Injection | 4.404 Standardized Uptake Value | Standard Deviation 2.2761 |
| Imaging Session 2 | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 65 Minute Post Injection | 4.675 Standardized Uptake Value | Standard Deviation 2.4489 |
| Imaging Session 2 | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 40 Minute Post Injection | 4.671 Standardized Uptake Value | Standard Deviation 2.4485 |
| Imaging Session 2 | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 90 Minute Post Injection | 4.691 Standardized Uptake Value | Standard Deviation 2.6445 |
| Relative Difference | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 40 Minute Post Injection | 0.0198 Standardized Uptake Value | Standard Deviation 0.16099 |
| Relative Difference | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 90 Minute Post Injection | 0.0506 Standardized Uptake Value | Standard Deviation 0.22251 |
| Relative Difference | Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging. | 65 Minute Post Injection | 0.0216 Standardized Uptake Value | Standard Deviation 0.17466 |
Secondary
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Safety was monitored throughout the duration of the subject's participation.
Time frame: Up to 8 weeks post contrast administration.
Population: The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any AE leading to Study Discontinuation | 1 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any TEAE | 18 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Total number of TEAEs | 47 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any TEAE at least related to Drug | 1 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Intesity-Mild | 3 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Intensity-Moderate | 8 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Intensity-Severe | 7 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any SAEs | 7 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any SAE at least related to Drug | 0 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any AE leading to Death | 2 number of adverse events |
| Imaging Session 1 | The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors. | Any AE leading to death at least related to Drug | 0 number of adverse events |