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NCT01383135 · ClinicalTrials.gov registry record · Early Phase 1
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
A Early Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 27
- Enrollment target
NCT01383135: Completed Early Phase 1 study, sponsored by Stanford University.
NCT01383135 is a Early Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 27 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01383135, a Early Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel)
Interventions
- DRUG F18-FPPRGD2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
What the finished NCT01383135 record still lists
NCT01383135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which F18-FPPRGD2 is the first listed.
NCT01383135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01383135 about?
NCT01383135 is a clinical study titled "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...
What is the current status of trial NCT01383135?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2010-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01383135?
The interventions under investigation include: F18-FPPRGD2 (DRUG).
Who is sponsoring clinical trial NCT01383135?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01383135's enrollment target sits among peer trials
27 963rd of 2000 higher than 1,024 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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