Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
Status
RECRUITING
Phase
PHASE2
Age
40 - 80 Years
Enrollments
20Conditions
Prostate CancerDrugs
Hyperpolarized 13C-PyruvateSummary
This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Mohummad Siddiqui, MD
Eligibility Criteria
Inclusion Criteria:
1. Age greater than 40 and less than 80 years
2. Clinical suspicion or history of prostate cancer reflected by one of the following:
* PSA > 4ng/ml
* Abnormal DRE exam
* Known tissue diagnosis of prostate cancer from prior workup
3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment
Exclusion Criteria:
1. Inability to undergo MRI scan
2. Inability to receive IV contrast as per institutional protocol.
Outcome Measures
Primary Outcome Measures
CTCAE v4.0 higher than grade 2
Secondary Outcome Measures
Accuracy of metabolic MRI to diagnose prostate cancer
Utility of metabolic MRI over standard MRI imaging in the diagnosis of prostate cancer
Correlative metabolic analysis of tissue metabolite concentrations versus cancer diagnosis
Timeline
Last Updated
July 19, 2024Start Date
January 7, 2021Today
February 5, 2025Completion Date ( Estimated )
December 31, 2027
Sponsors of this trial
Lead Sponsor
University of Maryland, Baltimore
RECRUITING 
21 - 64 Years