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Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.

NCT03497377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-05-07

No results posted yet for this study

Summary

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific \[18F\]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.

Conditions

Interventions

DRUG

18F-DCFPyL Injection

DRUG

18F-NaF

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Martin Pomper, MD,PhD · Department of Nuclear Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2020-04-30
Completion
2020-04-30

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 NCT03497377 on ClinicalTrials.gov