New MRI scan could reveal hidden acidity in prostate tumors
NCT ID NCT05851365
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests a new MRI technique that uses a special form of bicarbonate to measure how acidic prostate tumors are. Ten men with localized prostate cancer will receive an injection of hyperpolarized bicarbonate before an MRI scan. The goal is to see if this method is safe and can produce clear images of tissue acidity, which may help doctors better understand and treat prostate cancer in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hyperpolarized bicarbonate (13C)
- What this could lead to
- If successful, this imaging method could help doctors measure acidity in prostate tumors without a biopsy, potentially guiding treatment decisions.
- What could go wrong
- This is a very early pilot study with only 10 participants. It is testing feasibility and safety, not treatment effectiveness. The technique may not work as hoped or may not be practical for wider use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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1 person
The number who actually took part.
- Started
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Jul 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients age \>=18 years. 2. 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. 3. 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. 4. Patients must have planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/ magnetic resonance spectroscopy imaging) (MRSI). 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Demonstrates adequate organ function as defined below: 1. Adequate bone marrow function: * Absolute neutrophil count \>=1,500 cells/µL. * Platelets \>=75,000 cells/µL. * Hemoglobin \>=9.0 gm/dL. 2. 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. 3. 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. 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who because of general medical or psychiatric condition, or physiologic status, cannot give valid informed consent. 2. Patients unwilling or unable to undergo MR imaging, including patients with contraindications to Magnetic resonance imaging (MRI) as per UCSF radiology departmental guidelines. 3. 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. 4. Patients with contra-indications to injection of gadolinium contrast as per UCSF radiology departmental guidelines. 5. Patients who take carbonic anhydrase inhibitors (e.g. acetazolamide, dichlorphenamide, methazolamide). 6. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging. 7. 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. 8. 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. 9. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California, San Francisco
San Francisco, California, 94143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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