NCT02599194

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	18F-FSPG	Administered intravenously (IV)
DRUG	18F-FDG	Administered intravenously (IV)

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-12-14
• Completion: 2016-12-14
• First posted: 2015-11-06
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study