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Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT04698564
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of Maryland, Baltimore

Study Description
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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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Hyperpolarized 13C-Pyruvate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Hyperpolarized 13C-Pyruvate

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].


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Accuracy of metabolic MRI to diagnose prostate cancer [ Time Frame: Within three years post treatment ]
    To study the accuracy of hyperpolarized metabolic MRI to diagnose prostate cancer. Compare the prediction of cancer from the MRI scan compared to actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes. Prediction of cancer from MRI scan will be performed by assigning a standardized score (PIRADS v2.0). Actual diagnosis of cancer will be based on tissue pathology (with cancer grade characterized using the prostate cancer ISUP Grade Group system) from any procedure the patient undergoes.

  2. Utility of metabolic MRI over standard MRI imaging in the diagnosis of prostate cancer [ Time Frame: Within three years post treatment ]
    To examine the added utility of metabolic MRI over standard MRI imaging. Quantify the number of participants in which the MRI provided extra information that otherwise was not available during the course of the patient's workup.

  3. Correlative metabolic analysis of tissue metabolite concentrations versus cancer diagnosis [ Time Frame: Within three years post treatment ]
    To perform correlative metabolic analysis related to cancer diagnosis. Using the research tissue when it is available. Analyze tumor samples when available from participants and characterize the metabolite concentration (microgram/mg of tissue) within the tumor to determine how the concentration value compares to two outcomes of interest: 1: the numerical suspicion score (PIRADS v2.0 system) from the imaging from the patient and 2: The presence of cancer and grade of cancer (ISUP Grade Group system), when present, from pathology analysis performed on the tissue from the patient available. Analyze tumor samples when available from participants and characterize the metabolite concentration within the tumor to determine how this compares to the information from the imaging from the patient and pathology analysis performed on the tissue


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698564


Contacts
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Contact: Minhaj Siddiqui, MD 617-939-4823 msiddiqui@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mohummad Siddiqui, MD         
Sponsors and Collaborators
University of Maryland, Baltimore
More Information
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Responsible Party: University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT04698564    
Other Study ID Numbers: 18149GCCC
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases