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

ConditionsProstate Cancer Localized Prostate Carcinoma

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexMale

Age18+

SponsorRobert Flavell, MD, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Hyperpolarized Bicarbonate (13C)
Drug
Given IV
Magnetic Resonance imaging
Procedure/Surgery
Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Pre-surgical participants with prostate cancerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robert Flavell, MD, PhD

Lead sponsor

University of California, San Francisco

Sponsor institution

U.S. Army Medical Research Acquisition Activity

Collaborator

Bristol-Myers Squibb