18F-FSPG PET/CT for Cancer Patients on Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy

Conditions
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B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Metastatic Renal Cell Cancer, Progesterone Receptor Negative, Stage III Mesothelioma, Stage III Renal Cell Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV Mesothelioma, Stage IV Non-Small Cell Lung Cancer, Stage IV Renal Cell Cancer, Triple-Negative Breast Carcinoma

Intervention / Treatment
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* Drug: 18F-FSPG
* Drug: 18F-FDG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Intra-patient comparison of 2 different radiolabels
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FSPG and 18F-FDG Intragroup Comparision<br>Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. | Drug: 18F-FSPG<br>* Administered intravenously (IV)<br>* Other names: BAY94-9392;Drug: 18F-FDG<br>* Administered intravenously (IV)<br>* Other names: [18F]-Fluorodeoxyglucose ([18F]-FDG);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to up to 2 years | 
| 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). | Baseline and up to 2 years |