Brief Title
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Official Title
Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Change From Baseline in Maximum Standard Uptake Values (SUVmax)
Secondary Outcome
Response Assessment by RANO Criteria
Condition
Adult Giant Cell Glioblastoma
Intervention
18F-fludeoxyglucose (18F-FDG)
Study Arms / Comparison Groups
Glioblastoma Multiforme (GBM)
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
March 4, 2013
Completion Date
April 2019
Primary Completion Date
December 7, 2016
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sanjiv Gambhir, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01806675
Organization ID
IRB-25970
Secondary IDs
NCI-2013-00535
Responsible Party
Sponsor-Investigator
Study Sponsor
Sanjiv Sam Gambhir
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Sanjiv Gambhir, MD, PhD, Principal Investigator, Stanford University
Verification Date
September 2019