Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer

Sponsors

Lead Sponsor: University of Maryland, Baltimore

Source University of Maryland, Baltimore
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

Overall Status Not yet recruiting
Start Date February 1, 2021
Completion Date February 1, 2023
Primary Completion Date February 1, 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
CTCAE v4.0 higher than grade 2 Within three years post treatment
Secondary Outcome
Measure Time Frame
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
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hyperpolarized 13C-Pyruvate

Description: Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") [ 13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy. Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997].

Arm Group Label: Single-arm study in patients who are suspected or known to have prostate cancer

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.

Gender: Male

Minimum Age: 40 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Contact

Last Name: Minhaj Siddiqui, MD

Phone: 617-939-4823

Email: [email protected]

Verification Date

January 2021

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Single-arm study in patients who are suspected or known to have prostate cancer

Type: Experimental

Description: 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 Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov