Early Phase 1
N=27
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Breast Cancer · Non-Small-Cell Lung Cancer · Glioblastoma · Other Cancers
Bottom Line
View on ClinicalTrials.gov: NCT01383135 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Tracer Dosimetry by Organ — 0.3603; 0.0988; 0.8615; 0.5290 mSv/MBq
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- F18-FPPRGD2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tracer Dosimetry by Organ |
0.3603; 0.0988; 0.8615; 0.5290 | — |
| PRIMARY F18-FPPRGD2 Time-activity at Specified Timepoints |
26; 18; 8 | — |
| PRIMARY Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer |
95.7 | — |
| PRIMARY Specificity of F18 FPPRGD2 PET/CT in Breast Cancer |
100 | — |
| PRIMARY Glioblastoma Primary Tumor Response Assessed by PET Scan |
1.7; 1.3 | .034 sig |
| SECONDARY Glioblastoma Primary Tumor Response Assessed by CT Scan |
-11.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Healthy volunteers:
- Must be 18 years of age or older.
- Must have no known medical problems and have had a full medical exam within 6 months of the study.
- Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
- 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).
- 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:
- Greater than 18 years-old at the time of radiotracer administration
- Provides written informed consent
- Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy
- Able to remain still for duration of each imaging procedure (about one hour)
Exclusion Criteria
- Less than 18 years-old at the time of radiotracer administration
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT01383135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.