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NCT04167969 · ClinicalTrials.gov registry record · Phase 1
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT04167969: Recruiting Phase 1 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04167969 is a Phase 1 study of Prostate Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 16 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04167969, a Phase 1 study of Prostate Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.
Primary Outcome
Will be described using CTCAE version 5 criteria.
Conditions Studied
Interventions
- DRUG (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots
- DIAGNOSTIC_TEST PET/MRI/fluorescence imaging
- OTHER Blood and urine sampling
- PROCEDURE laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-02-17 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What NCT04167969 shows while recruiting
NCT04167969 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 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots is the first listed.
NCT04167969 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04167969 about?
NCT04167969 is a clinical study titled "The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer". The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. ...
What is the current status of trial NCT04167969?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-02-17. Estimated completion is 2026-11.
What conditions does trial NCT04167969 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04167969?
The interventions under investigation include: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots (DRUG), PET/MRI/fluorescence imaging (DIAGNOSTIC_TEST), Blood and urine sampling (OTHER), laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection (PROCEDURE).
Who is sponsoring clinical trial NCT04167969?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04167969 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
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 NCT04167969's enrollment target sits among peer trials
16 683rd of 735 higher than 50 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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