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Multiparametric MRI for Prostate Cancer Localization and Characterization Using Hyperpolarized Pyruvate (13C) Injection

NCT02647983 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-01-22

No results posted yet for this study

Summary

Prostate cancer is the most common malignancy among men in the United States and Canada. Suspicion of prostate cancer with modern screening tests, such as digital rectal exam (DRE) and prostate serum antigen (PSA) require ultrasound-guided biopsy for pathological diagnosis. However, this technique misses cancer in nearly one quarter of patients and finds clinically insignificant disease in another third of patients, resulting in over-treatment and unnecessary morbidity.

MRI is the best imaging method for prostate cancer detection, but current techniques cannot reliably predict tumour grade and are often unreliable for localizing cancer, particularly within the transition zone, where specificity is low. The primary objective of this pilot study is to evaluate the added benefit of localizing prostate cancer and predicting tumour grade with Hyperpolarized 13C MRI, in addition to traditional T2-weighted and diffusion-weighted MR imaging.

The investigators propose a pilot study, in men diagnosed with prostate cancer awaiting prostatectomy, with the specific goals of comparing pre-operative imaging findings to ground truth histology, using whole-mount prostate specimens. The results of this study will provide insight into the prostate cancer disease signatures with MRI and determine if there is added benefit for incorporation of this new technique into future clinical MRI protocols. If future imaging tests could determine the size, grade and extent of disease, this would open the door for less invasive, localized treatment options with reduced morbidity.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Hyperpolarized Pyruvate (13C) Injection

Hyperpolarized Pyruvate (13C) Injection is a MRI contrast agent.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Charles Cunningham, PhD · Sunnybrook Research Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Canada

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 NCT02647983 on ClinicalTrials.gov