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Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

18 Years
Not Enrolling
Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma, Other Cancers

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Trial Information

Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

Inclusion Criteria:

Healthy volunteers:

1. Must be 18 years of age or older.

2. Must have no known medical problems and have had a full medical exam within 6 months
of the study.

3. Must understand and voluntarily have signed an Informed Consent after its contents
have been fully explained.

4. Women of child bearing potential (as defined as women who are not post menopausal for
12 months or who have had no previous surgical sterilization) and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry, for the duration of study participation and for 30 days after
the last dose.

Cancer subjects:

1. Greater than 18 years-old at the time of radiotracer administration

2. Provides written informed consent

3. Diagnosed with advanced NSCLC, breast cancer, pancreatic cancer and GBM; patients
will undergo bevacizumab or Cyberknife therapy

4. Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria

1. Less than 18 years-old at the time of radiotracer administration

2. Pregnant or nursing

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Response of primary tumor to treatment after six weeks, based on each of 1. change in PET uptake from baseline 2. change in CT tumor size from baseline 3. PET EORTC response criteria 4. CT RECIST response criteria

Outcome Description:

We expect a 60-70% response rate to treatment. 20 subjects will provide 95% power at 5% error to detect a difference in SUV level between groups as small as two standard deviations.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Sanjiv Sam Gambhir M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Non-Small-Cell Lung Cancer
  • Glioblastoma
  • Other Cancers
  • Healthy volunteers
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Glioblastoma
  • Lung Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317