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

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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