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NCT04614363 · ClinicalTrials.gov registry record · Phase 1
68 Ga-PSMA for High Risk Prostate Cancer
A Phase 1 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT04614363: Completed Phase 1 study, sponsored by The Methodist Hospital Research Institute.
NCT04614363 is a Phase 1 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04614363, a Phase 1 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.
Primary Outcome
Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT.
Interventions
- DRUG 68Ga-PSMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-10-13 |
| Est. Completion | 2023-04-25 |
| Phase | Phase 1 |
What the finished NCT04614363 record still lists
NCT04614363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 1 intervention - of which 68Ga-PSMA is the first listed.
NCT04614363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04614363 about?
NCT04614363 is a clinical study titled "68 Ga-PSMA for High Risk Prostate Cancer". This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered...
What is the current status of trial NCT04614363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2020-10-13. Estimated completion is 2023-04-25.
What interventions are being tested in trial NCT04614363?
The interventions under investigation include: 68Ga-PSMA (DRUG).
Who is sponsoring clinical trial NCT04614363?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04614363's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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