NCT05851365 · Robert Flavell, MD, PhD
Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer
What this study is about
This is a single site, forward-looking 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.
View original scientific description
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.
Interventions
DRUG
Hyperpolarized Bicarbonate (13C)
Given IV
PROCEDURE
Magnetic Resonance imaging
Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
Primary outcome measures
Proportion of participants with a signal to noise ratio > 2
Time frame: Day of MR imaging (1 day)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients age \>=18 years.
- Patients must have biopsy-proven adenocarcinoma of the prostate; biopsy may be performed outside of University of California, San Francisco (UCSF) if detailed results of sextant biopsy are available.
- Tumor size of at least 1.0 cm in long axis on Magnetic resonance imaging (MRI) or ultrasound; if no prior imaging is available, at least 3 cores positive on biopsy.
- Patients must have planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/ magnetic resonance spectroscopy imaging) (MRSI).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Demonstrates adequate organ function as defined below:
- Adequate bone marrow function:
- Absolute neutrophil count \>=1,500 cells/µL.
- Platelets \>=75,000 cells/µL.
- Hemoglobin \>=9.0 gm/dL.
- Adequate hepatic function:
- Total bilirubin \<1.5x upper limits of normal (ULN) (within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<=1.5 X institutional upper limit of normal.
- Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<=1.5 X institutional upper limit of normal.
- Adequate renal function:
- Creatinine clearance \>= 50 calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients who because of general medical or psychiatric condition, or physiologic status, cannot give valid informed consent.
- Patients unwilling or unable to undergo MR imaging, including patients with contraindications to Magnetic resonance imaging (MRI) as per UCSF radiology departmental guidelines.
- Patients who cannot tolerate or have contra-indications to endorectal coil insertion, for example, patients with a prior abdominoperineal resection of the rectum or latex allergy.
- Patients with contra-indications to injection of gadolinium contrast as per UCSF radiology departmental guidelines.
- Patients who take carbonic anhydrase inhibitors (e.g. acetazolamide, dichlorphenamide, methazolamide).
- Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
- Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. No limit on number of prior prostate biopsies. Prior Transurethral Resection of the Prostate (TURP) is not allowed.
- Poorly controlled hypertension, with blood pressure at study entry \>160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
- Congestive heart failure or New York Heart Association (NYHA) status \>= 2. A history of clinically significant electrocardiogram (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter will be allowed on study.
Where
- San Francisco, California
Collaborators
U.S. Army Medical Research Acquisition Activity, Bristol-Myers Squibb
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations