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NCT04978675 · ClinicalTrials.gov registry record · Phase 1
An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer
A Phase 1 study of Prostate Adenocarcinoma and Localized Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT04978675: Completed Phase 1 study of Prostate Adenocarcinoma and Localized Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04978675 is a Phase 1 study of Prostate Adenocarcinoma and Localized Prostate Carcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04978675, a Phase 1 study of Prostate Adenocarcinoma and Localized Prostate Carcinoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This prospective pilot study will assess the feasibility of rh PSMA 7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting prostate cancer that may have come back (recurrent) in patients with increasing levels of prostate-specific antigen (PSA) following prostate surgery (biochemically recurrent). An increase in PSA levels alone does not tell the doctor where the cancer may be or how much cancer there may be. Imaging tests, like a bone scan, MRI, and/or computed tomography, are often performed to help the doctor learn where or how much cancer there is, and how best to treat the cancer. rhPSMA-7.3 is a radioactive tracer agent that when used with PET/MRI imaging may help diagnose and look for the spread of prostate cancer. Prostate-specific membrane antigen (PSMA) is a protein that is expressed in prostate cancer and this agent targets the PSMA molecule. Giving rh PSMA 7.3 during PET/MRI may help doctors better find where the cancer may be spreading and how much of it there is. The results of this trial may also guide in radiotherapy planning.
Primary Outcome
Will be evaluated on both a per-patient and per-region basis. Will estimate the PPV rate and corresponding 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- DRUG Fluorine F 18 rhPSMA-7.3
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-08-04 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 1 |
What the finished NCT04978675 record still lists
NCT04978675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT04978675 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04978675 about?
NCT04978675 is a clinical study titled "An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer". This prospective pilot study will assess the feasibility of rh PSMA 7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting prostate cancer that may have come back (recurrent) in patients with increasing levels of prostate-specific antigen (PSA) following prostate su...
What is the current status of trial NCT04978675?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2021-08-04. Estimated completion is 2024-06-04.
What conditions does trial NCT04978675 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Localized Prostate Carcinoma, Biochemically Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT04978675?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fluorine F 18 rhPSMA-7.3 (DRUG).
Who is sponsoring clinical trial NCT04978675?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04978675 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04978675's enrollment target sits among peer trials
29 80th of 99 higher than 20 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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.
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