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Study details
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Pilot Study of MR Imaging with Pyruvate (13C) to Detect High Grade Prostate Cancer

Ivan de Kouchkovsky, MD
NCT IDNCT02526368ClinicalTrials.gov data as of Apr 2026
Phase

EARLY_PHASE1

Target enrollment

80

Study length

about 11 years

Ages

18+

Sex

Male only

Locations

1 site in CA

What this study is about

This trial is testing if magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea can help find prostate cancer that has poorly differentiated cells (high-grade) and is only in the original location. MRSI with hyperpolarized carbon (13C) pyruvate may assist in diagnosing prostate cancer and distinguishing high-grade from low-grade prostate cancer.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Hyperpolarized 13C,15N2-urea
  • 2.Take Hyperpolarized 13C-Pyruvate
  • 3.Undergo Magnetic Resonance Spectroscopic Imaging

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
topical

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

BLOOD AND BLOOD FORMING ORGANS

Drug routes

topical (Topical Cream)

Endpoints

Primary: Mean Urea AUC (Cohort B), Mean Urea AUC by pathological grade (Cohort A), Mean lactate area under curve (AUC) (Cohort B), Mean lactate area under curve (AUC) by pathological grade (Cohort A)

Secondary: Compare lactate/pyruvate area under curve (AUC) with Prostate Imaging Reporting and Data System (PI-RADS), Compare urea AUC with PI-RADS, Mean difference in Intra-patient Urea AUC, Mean difference in Intra-patient lac/pyr AUC, Optimal cut-off value of lac/pyr area under the curve (AUC) (Cohort A), Optimal cut-off value of lac/pyr area under the curve (AUC) (Cohort B), Optimal cut-off value of urea AUC (Cohort A), Optimal cut-off value of urea AUC (Cohort B)

Body systems

Oncology