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NCT03073395 · ClinicalTrials.gov registry record · Phase 1
Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer
A Phase 1 study of Prostate Cancer and Renal Cancer, sponsored by Five Eleven Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03073395: Completed Phase 1 study of Prostate Cancer and Renal Cancer, sponsored by Five Eleven Pharma.
NCT03073395 is a Phase 1 study of Prostate Cancer and Renal Cancer that has completed, run by Five Eleven Pharma. The registered enrollment target is 30 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03073395, a Phase 1 study of Prostate Cancer and Renal Cancer, has completed, sponsored by Five Eleven Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.
Primary Outcome
Standard uptake value (SUV) of \[68Ga\]P16-093 in apparent lesions detected by PET/CT.
Conditions Studied
Interventions
- DRUG [68Ga]P16-093
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 1 |
What the finished NCT03073395 record still lists
NCT03073395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which [68Ga]P16-093 is the first listed.
NCT03073395 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03073395 about?
NCT03073395 is a clinical study titled "Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer". An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients pos...
What is the current status of trial NCT03073395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-07-21. Estimated completion is 2023-10-27.
What conditions does trial NCT03073395 study?
This clinical trial studies the following conditions: Prostate Cancer, Renal Cancer.
What interventions are being tested in trial NCT03073395?
The interventions under investigation include: [68Ga]P16-093 (DRUG).
Who is sponsoring clinical trial NCT03073395?
This trial is sponsored by Five Eleven Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03073395 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03073395's enrollment target sits among peer trials
30 583rd of 735 higher than 128 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
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