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NCT03861676 · ClinicalTrials.gov registry record · Early Phase 1
Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT
A Early Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03861676: Recruiting Early Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03861676 is a Early Phase 1 study of Prostate Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861676, a Early Phase 1 study of Prostate Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. In the PI's clinical trial, the uninvolved regions (as defined by combined PET-MR-biopsy data) will not be targeted and receive only fall-off dose, which we have shown to be associated with reductions in toxicity.
Primary Outcome
Percent coverage of the combined PET-MR based tumor volume achieved when using iRUF intraoperative dosimetry. PET-MR tumor volume D90 will be defined on pre-treatment PET-MR fusion, and dose from seeds will be calculated on post-implant MR/CT (Day \~30); the two volumes will be co-registered to determine tumor volume coverage.
Conditions Studied
Interventions
- RADIATION Focal brachytherapy with PSMA PET imaging
- DRUG (18F)DCFPyL
Study Locations (1)
Maryland
- SKCCC at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-08-03 |
| Est. Completion | 2033-12 |
| Phase | Early Phase 1 |
What NCT03861676 shows while recruiting
NCT03861676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 2 interventions - of which Focal brachytherapy with PSMA PET imaging is the first listed.
NCT03861676 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03861676 about?
NCT03861676 is a clinical study titled "Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT". The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. ...
What is the current status of trial NCT03861676?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-08-03. Estimated completion is 2033-12.
What conditions does trial NCT03861676 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03861676?
The interventions under investigation include: Focal brachytherapy with PSMA PET imaging (RADIATION), (18F)DCFPyL (DRUG).
Who is sponsoring clinical trial NCT03861676?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03861676 being conducted?
This trial has 1 study location across Maryland. 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 NCT03861676's enrollment target sits among peer trials
20 653rd of 735 higher than 69 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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