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Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT

NCT03861676 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-13

No results posted yet for this 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.

Conditions

Interventions

RADIATION

Focal brachytherapy with PSMA PET imaging

Focal brachytherapy with PSMA PET imaging. Focal (partial prostate gland) brachytherapy following 18F-DCFPyl PET/CT radiotracer imaging. Patients will also undergo pre-treatment transperineal mapping biopsy.

DRUG

(18F)DCFPyL

18F-DCFPyl PET/CT scan

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Daniel Song, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2028-12-31
Completion
2033-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861676 on ClinicalTrials.gov