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

Phase 2

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
18F-FSPG and 18F-FDG Intragroup Comparision	18F-FDG	Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
18F-FSPG and 18F-FDG Intragroup Comparision	18F-FSPG	Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Locations (1): Stanford University Medical Center
🇺🇸
Stanford, California, United States