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NCT02048150 · ClinicalTrials.gov registry record · Phase 1
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02048150: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT02048150 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02048150, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in visualization of the prostate. Attaching a fluorescence, a substance that emits radiation that is visible, to the anti-PMSA antibody and injecting it into the body may help identify the tumor when specialized microscopes are used.
Primary Outcome
The main fluorescence metric will be the minimum fluorescence observed in 10 sampled high power fields from a single representative cancerous section taken per patient. Other metrics will be the mean fluorescence observed in the 10 sampled high power fields, and the median fluorescence observed. The minimum fluorescence is chosen based on the concept that the primary focus is on observing the fluorescence, and areas of peak fluorescence greatly influence the mean, and also have some influence on
Interventions
- OTHER pharmacological study
- PROCEDURE robot-assisted laparoscopic surgery
- OTHER Laboratory Biomarker
- BIOLOGICAL anti-PSMA monoclonal antibody MDX1201-A488
- OTHER diffuse optical imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-03-13 |
| Est. Completion | 2023-02-01 |
| Phase | Phase 1 |
What the finished NCT02048150 record still lists
NCT02048150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which pharmacological study is the first listed.
NCT02048150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02048150 about?
NCT02048150 is a clinical study titled "Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer". This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in visualization of the prostate. Attaching a fluorescence, a substance that emits radiation that is visible, to the anti-PMSA...
What is the current status of trial NCT02048150?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2015-03-13. Estimated completion is 2023-02-01.
What interventions are being tested in trial NCT02048150?
The interventions under investigation include: pharmacological study (OTHER), robot-assisted laparoscopic surgery (PROCEDURE), Laboratory Biomarker (OTHER), anti-PSMA monoclonal antibody MDX1201-A488 (BIOLOGICAL), diffuse optical imaging (OTHER).
Who is sponsoring clinical trial NCT02048150?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02048150's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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