Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
Overview
- Phase
- Phase 1
- Intervention
- 18F-fludeoxyglucose (18F-FDG)
- Conditions
- Adult Giant Cell Glioblastoma
- Sponsor
- Sanjiv Sam Gambhir
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Maximum Standard Uptake Values (SUVmax)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.
Detailed Description
PRIMARY OBJECTIVE • Evaluate 18F-FPPRGD2 and 18F-FDG as PET/CT or PET/MRI radiotracers for imaging prediction and assessment of response to anti-angiogenesis therapy in participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC). SECONDARY OBJECTIVE • Progression-free survival (PFS) at up to 1 year after initial scans and treatment OUTLINE: Patients undergo 18F-FPPRGD2 and 18F-FDG PET/CT or PET/MRI medical imaging at baseline and at regular medical care follow-up (6 to 12 weeks). After completion of study imaging, patients are followed up at 12 months.
Investigators
Sanjiv Sam Gambhir
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Provides written informed consent
- •Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis
- •Able to remain still for duration of each imaging procedure (about one hour)
Exclusion Criteria
- •Pregnant or nursing
- •Contraindication to MRI
- •History of renal insufficiency (only for MRI contrast administration)
Arms & Interventions
Glioblastoma Multiforme (GBM)
Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)
Intervention: 18F-fludeoxyglucose (18F-FDG)
Glioblastoma Multiforme (GBM)
Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)
Intervention: 18F-FPPRGD2
Gynecological Cancers
Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
Intervention: 18F-fludeoxyglucose (18F-FDG)
Gynecological Cancers
Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
Intervention: 18F-FPPRGD2
Renal Cell Cancer (RCC)
Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
Intervention: 18F-fludeoxyglucose (18F-FDG)
Renal Cell Cancer (RCC)
Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
Intervention: 18F-FPPRGD2
Outcomes
Primary Outcomes
Change From Baseline in Maximum Standard Uptake Values (SUVmax)
Time Frame: At baseline and 6 weeks
Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.
Secondary Outcomes
- Tumor Response Rate by EORTC Criteria(At baseline and 6 weeks)
- Response Assessment by RANO Criteria(At baseline and 6 weeks)
- Change in Tumor Size(9 to 12 weeks)
- Progression-free Survival (PFS)(1 year)