Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
NCT02526368 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-04-30
Summary
This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue
Conditions
- Prostate Cancer
- Localized Prostate Carcinoma
Interventions
- DRUG
-
Hyperpolarized 13C-Pyruvate
Given IV
- DRUG
-
Hyperpolarized 13C,15N2-urea
Given IV
- PROCEDURE
-
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Sponsors & Collaborators
-
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
collaborator NIH -
American Cancer Society, Inc.
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
Ivan de Kouchkovsky, MD
lead OTHER
Principal Investigators
-
Ivan de Kouchkovsky, MD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-22
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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