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Clinical trial

A Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer (pyruvate)

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Last updated:1st Aug 2015

This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy.
 

Study Type: Interventional

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Single Group Assignment

Masking: Open Label

Primary Purpose: Diagnostic

Official Title: A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer

Estimated Enrollment: 50

Study Start Date: August 2015

Estimated Study Completion Date: December 2019

Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
 

Arms:

Experimental: Pre-surgical Prostate Cancer patients

A minimum of 20 patients will be required to have high-risk localized disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.

Magnetic Resonance (MR) scan using pyruvate (13C) injection prior to prostate surgery.Participants will remain monitored on the study until the time of your radical prostatectomy or 30 days after the pyruvate (13C) injection, whichever is longer.

Category Value
Study start date 2015-08-01

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