Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
NCT ID: NCT04698564
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2020-12-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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 \[Koletzko et al., 1997\].
Interventions
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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 \[Koletzko et al., 1997\].
Eligibility Criteria
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Inclusion Criteria
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
2. Inability to receive IV contrast as per institutional protocol.
40 Years
80 Years
MALE
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Mohummad Siddiqui, MD
Role: primary
Other Identifiers
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18149GCCC ; HP-00084316
Identifier Type: -
Identifier Source: org_study_id
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