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

Study Purpose

The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data. The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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). 5. 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 non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01383135
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stanford University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sanjiv Gambhir, MD, PhD
Principal Investigator Affiliation	Stanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma, Other Cancers

Additional Details

The tracer [18F]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.

Arms & Interventions

Arms

Other: Healty Volunteers

Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.

Experimental: Breast Cancer

Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection.

Experimental: Glioblastoma Multiform (brain)

Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection.

Experimental: Lung Cancer

Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection.

Interventions

Drug: - F18-FPPRGD2

Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University School of Medicine, Stanford, California

Status

Address

Stanford University School of Medicine

Stanford, California, 94305

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