Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- CTCAE v4.0 higher than grade 2
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than 40 and less than 80 years
- •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
- •Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment
Exclusion Criteria
- •Inability to undergo MRI scan
- •Inability to receive IV contrast as per institutional protocol.
Arms & Interventions
Single-arm study in patients who are suspected or known to have prostate cancer
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
Intervention: Hyperpolarized 13C-Pyruvate (Drug)
Outcomes
Primary Outcomes
CTCAE v4.0 higher than grade 2
Time Frame: Within three years post treatment
Quantify the number of participants who get this scan and have treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2. Determine the number of participants who successfully complete a scan which meets a minimum quality standard as measured by signal to noise ratio on the scan. hyperpolarized metabolic MRI in the diagnosis of prostate cancer.
CTCAE v4.0 Higher Than Grade 2
Time Frame: Within three years post treatment
Quantify the number of participants who get this scan and have treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2. Determine the number of participants who successfully complete a scan which meets a minimum quality standard as measured by signal to noise ratio on the scan, hyperpolarized metabolic MRI in the diagnosis of prostate cancer.
Secondary Outcomes
- Accuracy of metabolic MRI to diagnose prostate cancer(Within three years post treatment)
- Utility of metabolic MRI over standard MRI imaging in the diagnosis of prostate cancer(Within three years post treatment)
- Correlative metabolic analysis of tissue metabolite concentrations versus cancer diagnosis(Within three years post treatment)
- Accuracy of Metabolic MRI to Diagnose Prostate Cancer(Within three years post treatment)
- Utility of Metabolic MRI Over Standard MRI Imaging in the Diagnosis of Prostate Cancer(Within three years post treatment)
- Correlative Metabolic Analysis of Tissue Metabolite Concentrations Versus Cancer Diagnosis(Within three years post treatment)