CompletedEarly Phase 1NCT01383135

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

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.

Checked against the public recordLast updated Jan 12, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhaseEarly Phase 1
U.S. locations1
SponsorStanford University
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Early Phase 1
Sponsor
Stanford University
Interventions being studied
Drug: F18-FPPRGD2
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford University School of MedicineStanford, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2024. Always confirm current availability with the study team.

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