Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

NCT04698564 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 18149GCCC ; HP-00084316
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• CTCAE v4.0 higher than grade 2

  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.

  Within three years post treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Hyperpolarized 13C-Pyruvate

Interventions

Hyperpolarized 13C-Pyruvate DRUG

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 \[Koletzko et al., 1997\].

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to undergo MRI scan
• Inability to receive IV contrast as per institutional protocol.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Minhaj Siddiqui, MD

CONTACT

617-939-4823; msiddiqui@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: January 7, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)