An Early Phase 1 interventional study of Hyperpolarized Bicarbonate (13C) and Magnetic Resonance imaging in Prostate Cancer and Localized Prostate Carcinoma, sponsored by Robert Flavell, MD, PhD. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Robert Flavell, MD, PhD · Early Phase 1, Interventional, and Diagnostic
This is a single site, prospective pilot study to determine the feasibility and safety of the administration of HP 13C bicarbonate in 10 patients with prostate cancer to determine potential hydrogen (pH) values in surrounding tissue. The proposed study will evaluate pre-surgical participants with histologically confirmed localized prostate cancer who receive infusion of hyperpolarized 13C injection prior to MR imaging with endorectal coil.
PRIMARY OBJECTIVE:
I. To determine the feasibility of tumor pH measurement in men with prostate cancer using hyperpolarized 13C bicarbonate imaging.
SECONDARY OBJECTIVE:
I. To determine the safety of administration of hyperpolarized 13C-bicarbonate.
EXPLORATORY OBJECTIVES:
I. To correlate the measurement of tissue pH with pathologic grade.
II. To correlate tissue pH maps with immunohistochemistry staining (IHC), gene expression (RNA-Seq), and spatial transcriptomics. *Bristol Myers Squibb (BMS) collaboration
OUTLINE:
Men with biopsy-proven adenocarcinoma of the prostate scheduled to undergo radical prostatectomy at University of California, San Francisco (UCSF) within 12 weeks of enrollment will receive infusion with hyperpolarized 13C bicarbonate and undergo metabolic MR imaging with endorectal coil. Participants will be followed for 5-9 days after the hyperpolarized 13C-bicarbonate injection, or removal from study, or until death, whichever occurs first. Participants removed from study for unacceptable study related adverse event(s) will be followed until resolution or stabilization (as determined by the investigator) or until initiation of new anti-cancer therapy, whichever occurs first.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Robert Flavell, MD, PhD is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Demonstrates adequate organ function as defined below:
Adequate bone marrow function:
Adequate hepatic function:
Adequate renal function:
Exclusion Criteria:
The hyperpolarized 13C bicarbonate injection includes the administration of 35 mL injected intravenously (IV) at a rate of 5 mL/second followed by a 20 mL saline flush at 5 mL/second, followed by magnetic resonance (MR) imaging. The intervention will include routine and safety assessments 5 to 9 days after the injection.
Drug: Hyperpolarized Bicarbonate (13C) · Procedure: Magnetic Resonance imaging
Given IV
Also known as: Hyperpolarized (HP) bicarbonate 13 (13C), HP C13
Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
Also known as: Magnetic Resonance scan, MR scan
Proportion of participants with a signal to noise ratio > 2
The feasibility of a study will be determined by the ability to generate adequate signal to noise ratio to measure acidity (pH) in tumor or adjacent healthy tissue. This study will be considered successful if the 13C bicarbonate (CO2) and 13C-CO2 resonances in tumor or normal prostate are qualitatively detectable and signal to noise ratios are greater than 2. The point estimation and 95% confidence intervals (CI) of the participants having sufficient signal to noise ratio will be obtained using the Wilson Score confidence interval method.
Time frame: Day of MR imaging (1 day)
Percentage of participants with reported treatment-emergent adverse events
To assess the safety of the administration of hyperpolarized 13C bicarbonate; adverse events will be collected and recorded by type, severity (grade) and attribution according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The percentage of participants with grade 2 and higher, treatment-emergent adverse events will be reported.
Time frame: Up to 9 days
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Robert Flavell, MD, PhD