Trial Outcomes & Findings for Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging (NCT NCT04698564)

Last Updated: 2026-07-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Within three years post treatment

Results posted on

2026-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	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 \[Koletzko et al., 1997\].
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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 \[Koletzko et al., 1997\].
Overall Study Insurance issues. Withdrawn from study	1

Baseline Characteristics

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer n=4 Participants 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 \[Koletzko et al., 1997\].
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=20 Participants
Age, Categorical >=65 years	1 Participants n=20 Participants
Age, Continuous	59 years STANDARD_DEVIATION 7.53 • n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	4 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	3 Participants n=20 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	4 Participants n=20 Participants

PRIMARY outcome

Timeframe: Within three years post treatment

Population: This study was terminated prematurely. No patients had treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2 until study termination. Four participants were enrolled; however, no usable data were obtained. * One withdrew before the visit * One could not complete the HP MRI due to pyruvate QC failure, so the HP scan was not completed. * Two patients completed scans, but the SNR was too low (below minimum quality standard) for analysis.

Outcome measures

Outcome measures
Measure	Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer n=3 Participants 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 \[Koletzko et al., 1997\].
CTCAE v4.0 Higher Than Grade 2	0 Participants

SECONDARY outcome

Timeframe: Within three years post treatment

Population: This study was terminated prematurely. Four participants were enrolled; however, no usable data were obtained. * One withdrew before the visit * One could not complete the HP MRI due to pyruvate QC failure, so the HP scan was not completed. * Two patients completed scans, but the SNR was too low (below minimum quality standard) so no comparison could be done with actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dirk Mayer

University of Maryland Baltimore

Phone: 410 706 2720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place