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NCT04685811 · ClinicalTrials.gov registry record · Phase 1
Evaluation of PSMA Antagonist Produced by Two Different Methods
A Phase 1 study of Metastatic Prostate Adenocarcinoma, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04685811: Completed Phase 1 study of Metastatic Prostate Adenocarcinoma, sponsored by Weill Medical College of Cornell University.
NCT04685811 is a Phase 1 study of Metastatic Prostate Adenocarcinoma that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 16 participants, below the 125-participant average among 18 other Metastatic 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
NCT04685811, a Phase 1 study of Metastatic Prostate Adenocarcinoma, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.
Primary Outcome
Single score Intraclass Correlation Coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying pathologic lesions. The ICC, based on a one-way random effects model was used to assess reliability. The ICC ratios in this data shows the top five lesions with the greatest PSMA uptake (SUV) in each patient. This is a measure of the variance of interest (for the patient's lesion) over the total variance (from all data points for t
Conditions Studied
Interventions
- DRUG 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron
Study Locations (1)
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 1 |
What the finished NCT04685811 record still lists
NCT04685811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 125-participant average among 18 other Metastatic Prostate Adenocarcinoma trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Metastatic Prostate Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron is the first listed.
NCT04685811 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04685811 about?
NCT04685811 is a clinical study titled "Evaluation of PSMA Antagonist Produced by Two Different Methods". Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research stud...
What is the current status of trial NCT04685811?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-12-09. Estimated completion is 2021-06-30.
What conditions does trial NCT04685811 study?
This clinical trial studies the following conditions: Metastatic Prostate Adenocarcinoma.
What interventions are being tested in trial NCT04685811?
The interventions under investigation include: 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron (DRUG).
Who is sponsoring clinical trial NCT04685811?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04685811 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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