An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
Overview
- Phase
- Phase 2
- Intervention
- 18F-FSPG
- Conditions
- B-Cell Neoplasm
- Sponsor
- Andrei Iagaru
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Andrei Iagaru
Associate Professor of Radiology
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Able to complete a PET/CT scan without the use of sedation
- •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
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
Arms & Interventions
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.
Intervention: 18F-FSPG
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.
Intervention: 18F-FDG
Outcomes
Primary Outcomes
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Time Frame: 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 Outcomes
- Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs(Baseline and up to 2 years)
- Number of Treatment-Related Adverse Events(Baseline to up to 2 years)