B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Metastatic Renal Cell Cancer, Progesterone Receptor Negative, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage III Mesothelioma, Stage III Renal Cell Cancer, Stage IV Breast Cancer, Stage IV Mesothelioma, Stage IV Non-Small Cell Lung Cancer, Stage IV Renal Cell Cancer, Triple-Negative Breast Carcinoma
Conditions
Brief summary
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.
Detailed description
OUTLINE: Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG \[18F-(S)-4-(3-fluoropropyl)-L-glutamic acid\] or 18F-FDG (\[18F\]-fluorodeoxyglucose), before and after therapeutic treatment. PRIMARY OBJECTIVE: Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients. SECONDARY OBJECTIVES: * Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG. * Safety and tolerability of 18F-FSPG and 18F-FDG.
Interventions
DRUG18F-FSPG
Administered intravenously (IV)
DRUG18F-FDG
Administered intravenously (IV)
Sponsors
National Cancer Institute (NCI)
Andrei Iagaru
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Intra-patient comparison of 2 different radiolabels
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Able to complete a PET/CT scan without the use of sedation * Females: * Of childbearing potential must: * Not be nursing * Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT * Not of childbearing potential must be: * Physiologically postmenopausal (cessation of menses for more than 1 year) * Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy) * Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent * Scheduled to begin therapy * The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options) * Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion) * No clinically relevant deviations in renal function (serum creatinine \> grade 2 Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
Exclusion criteria
* Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration * Known sensitivity to 18F FSPG or components of the preparation * Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment | Baseline and up to 2 years | Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-Related Adverse Events | Baseline to up to 2 years | Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion. |
| Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Baseline and up to 2 years | Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18F-FSPG and 18F-FDG Intragroup Comparision Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
18F-FSPG: Administered intravenously (IV)
18F-FDG: Administered intravenously (IV) | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | 18F-FSPG and 18F-FDG Intragroup Comparision |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 69.1 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 5 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
Time frame: Baseline and up to 2 years
Population: Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis mean of differences would have a dispersion, but an analysis for difference of means is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment | 18F-FSPG | -1.69 g/mL |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment | 18F-FDG | -0.64 g/mL |
Secondary
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
Time frame: Baseline and up to 2 years
Population: * Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel).~* Lesions detected at either before or after treatment only are reported as the difference from zero.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / liver metastatis | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / adrenal mass, left | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / hepatic dome | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / lung base metastatis, lower lobe right | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / lung metastatis, left | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / infrascapular subcut | 0.2 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / abdominal wall, upper quadrant right | 7.6 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / adajcent subcarinal lymph node | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / aortopulmonary window lymph node | -1.1 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / hilar lymph node, left | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / infraspinatus mm, right | 10.4 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / lingula nodule | -1.7 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / mass, upper lobe left | -8.1 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / mass, lower lobe right | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / nodule 1, lower lobe right | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / nodule 2, upper lobe right | -1.7 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / nodule, upper lobe right | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / paraesophageal lymph node | 0.9 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / post-basal, lower lobe right | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / subcarinal lymph node | 1.4 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / adrenal mass, right | 3.1 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / aortopulmonary window lymph node, left | 1.1 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / gluteal subcutaneous nodule | 0.2 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / interlobar | 2.4 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / kidney midpole, right | -1.2 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / omental nodule | -0.2 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / paratracheal lymph node, right | 0.6 cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / parotid, right | NA cm2 |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / retroperitoneal lymph node, left | 1.6 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / nodule 1, lower lobe right | -0.8 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / omental nodule | 1.2 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / adrenal mass, left | 11.3 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / nodule 2, upper lobe right | -1.5 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / hepatic dome | -2.0 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / liver metastatis | -1.3 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / gluteal subcutaneous nodule | 0.2 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / lung base metastatis, lower lobe right | 1.4 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / nodule, upper lobe right | -0.4 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Adrenal / lung metastatis, left | -0.7 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / parotid, right | -2.3 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / infrascapular subcut | NA cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / paraesophageal lymph node | NA cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / abdominal wall, upper quadrant right | 6.9 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / interlobar | NA cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / adajcent subcarinal lymph node | 3.0 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / post-basal, lower lobe right | -3.6 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / aortopulmonary window lymph node | -2.8 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / paratracheal lymph node, right | -2.0 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / hilar lymph node, left | -2.3 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / subcarinal lymph node | 11.4 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / infraspinatus mm, right | 10.2 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / kidney midpole, right | -1.4 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / lingula nodule | -2.7 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / adrenal mass, right | 7.1 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / mass, upper lobe left | -6.4 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / retroperitoneal lymph node, left | 2.2 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Lung / mass, lower lobe right | -14.5 cm2 |
| Difference in Lesion Size as Detected by 18F-FDG | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs | Renal / aortopulmonary window lymph node, left | -1.2 cm2 |
Secondary
Number of Treatment-Related Adverse Events
Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
Time frame: Baseline to up to 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-FSPG and 18F-FDG Intragroup Comparision | Number of Treatment-Related Adverse Events | 18F-FDG | 0 adverse events |
| 18F-FSPG and 18F-FDG Intragroup Comparision | Number of Treatment-Related Adverse Events | 18F-FSPG | 0 adverse events |