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Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

NCT03619655 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-10-31

No results posted yet for this study

Summary

The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.

Conditions

Interventions

PROCEDURE

SPECT CT

MDP (99mTc-MDP) administration, about 180 min post-injection: whole body scan followed by a SPECT CT of regions designated by a board certified Nuclear Medicine physician after review of the whole body scan.

DRUG

18F-DCFPyL PET/CT

A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

DRUG

18F-NaF PET/CT

A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose. At the 1 hour post injection time, total Whole Body Images take approximately 40 - 60 minutes depending on the height of the patient.

PROCEDURE

WB-MRI

Whole body MRI exam (total examination time \< 50 minutes)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Lilja Solnes, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2022-11-14
Completion
2022-11-14
FDA Drug
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 NCT03619655 on ClinicalTrials.gov