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Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam

NCT04286386 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2026-04-29

No results posted yet for this study

Summary

This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.

Conditions

  • Prostate Adenocarcinoma

Interventions

PROCEDURE

Surgical Procedure

Undergo standard of care surgery

OTHER

Hyperpolarized Carbon C 13 Pyruvate

Given IV

PROCEDURE

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Tharakeswara Bathala · M.D. Anderson Cancer Center

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04286386 on ClinicalTrials.gov