Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Pro… (NCT05851365) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer
United States1 participantsStarted 2023-07-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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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:
✓. Adequate hepatic function:
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.
What they're measuring
1
Proportion of participants with a signal to noise ratio > 2
✕. 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.