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RecruitingEarly Phase 1

Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer

A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Localized Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for 5-9 days after the hyperpolarized 13C-bicarbonate injection, or removal from study, or until death, whichever occurs first."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether an injection of hyperpolarized bicarbonate (13C) is safe and can help MRI scans measure how acidic tissue near prostate cancer is. It is for 10 adults with prostate cancer that has not spread who plan to have surgery. The scan uses a device placed in the rectum.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • A biopsy (a small tissue sample) shows prostate adenocarcinoma, a type of prostate cancer. Biopsies done outside UCSF must have detailed results.
  • Your tumor is at least 1 centimeter long on MRI or ultrasound. If you have no earlier scans, at least 3 biopsy samples must show cancer.
  • You plan to have your prostate removed at UCSF within 12 weeks after the study scan.
  • You can do all usual activities, or have limits only on hard physical activity.
  • Your blood cell counts and liver and kidney tests meet the study's safety limits.
  • You can understand the study and are willing to sign a consent form.

Who can't join

  • A medical or mental health condition keeps you from giving valid consent.
  • You cannot or do not want to have an MRI, or you cannot safely receive gadolinium, a dye used for MRI scans.
  • You cannot safely have or tolerate the scan device in your rectum, such as because of past surgery to remove the rectum or a latex allergy.
  • You take a carbonic anhydrase inhibitor, such as acetazolamide, dichlorphenamide, or methazolamide.
  • You have a metal hip implant or another metal implant or device that harms scan quality.
  • You have had freezing treatment or surgery for prostate cancer, radiation to the prostate or pelvis, or TURP (surgery to remove prostate tissue through the urine tube). Past prostate biopsies are allowed.
  • Your blood pressure is poorly controlled and above 160/100 when you enter the study. Blood pressure medicines may be added to help you qualify.
  • You have heart failure, heart symptoms with ordinary activity or less, certain serious abnormal heart tracing results, a family history of long QT syndrome (an electrical heart problem), or a heart attack in the past 6 months. Atrial fibrillation or flutter is allowed if your heart rate is controlled.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

CA