Clinical Trial: 18F FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase I/II 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. We will assess the uptake of this novel radiopharmaceutical in subjects with breast cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring antiangiogenesis treatment.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Evaluate 18F FPPRGD2 PET/CT or PET/MRI for prediction and early assessment of response to anti-angiogenesis therapy in patients with non-small cell lung cancer (NSCLC), breast cancer, glioblastoma multiforme (GBM) and other cancers.

OUTLINE:

Patients undergo 18F FPPRGD2 PET/CT or PET/MRI at baseline, 1 week, and 6 weeks (or standard of care follow-up) and 18F FDG PET/CT at baseline and 6 weeks (or standard of care follow-up) .

After completion of study imaging, patients are followed up at 12 months.


Sponsor: Sanjiv Sam Gambhir

Current Primary Outcome: Change in maximum standard uptake values (SUVmax) on 18F FPPRGD2 and 18F FDG PET [ Time Frame: From baseline up to 6 weeks ]

Response to treatment is based on the change in PET uptake, change in CT tumor size, PET European Organization for Research and Treatment of Cancer (EORTC) response criteria, and CT Response Evaluation Criteria In Solid Tumors (RECIST) response criteria. Each of the four response criteria will be dichotomized into responding or non-responding to treatment. The Mann-Whitney test and logistic regression of response/non-response will be performed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Progression-free survival [ Time Frame: Up to 1 year ]

For each SUV measure patients will be divided into two groups based on whether their SUV uptake is above or below the median. Kaplan-Meir curves for the two groups will be plotted and a log-rank test for difference in PFS will be performed. A Cox proportional-hazards regression of PFS on group will be performed.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: March 5, 2013
Date Started: March 2013
Date Completion: March 2019
Last Updated: March 12, 2017
Last Verified: March 2017