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MRI with Hyperpolarized Bicarbonate for Prostate Cancer
Phase < 1
Recruiting
Research Sponsored by Robert Flavell, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 days
Awards & highlights
Study Summary
This trial will test the safety of an injection in people with prostate cancer to measure hydrogen levels in the tissue.
Who is the study for?
Men over 18 with localized prostate cancer confirmed by biopsy, who are fit (ECOG status of 0 or 1), and have adequate organ function. They must understand the study and consent to participate. Excluded are those with prior prostate cancer treatments like cryosurgery or radiotherapy, inability to undergo MRI, latex allergy, certain medication use, metallic implants affecting MR imaging quality, uncontrolled high blood pressure, significant heart conditions or recent heart attack.Check my eligibility
What is being tested?
The trial is testing a new method using hyperpolarized bicarbonate (13C) injections followed by MRI scans to measure pH levels in prostate tissue before surgery. It's a small-scale pilot study at UCSF for men scheduled for radical prostatectomy within 12 weeks after the imaging tests.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include reactions related to the infusion of hyperpolarized bicarbonate (13C), discomfort from endorectal coil during MRI scans, and typical risks associated with gadolinium contrast agents used in some MRIs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with a signal to noise ratio > 2
Secondary outcome measures
Percentage of participants with reported treatment-emergent adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pre-surgical participants with prostate cancerExperimental Treatment2 Interventions
The hyperpolarized 13C bicarbonate injection includes the administration of 35 mL injected intravenously (IV) at a rate of 5 mL/second followed by a 20 mL saline flush at 5 mL/second, followed by magnetic resonance (MR) imaging. The intervention will include routine and safety assessments 5 to 9 days after the injection.
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Who is running the clinical trial?
Robert Flavell, MD, PhDLead Sponsor
3 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Prostate Cancer
24 Patients Enrolled for Prostate Cancer
U.S. Army Medical Research Acquisition ActivityFED
20 Previous Clinical Trials
1,981 Total Patients Enrolled
4 Trials studying Prostate Cancer
171 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is at least 1.0 cm big on an MRI or ultrasound, or I had a positive biopsy with at least 3 cores.My kidney function is good enough for the trial, with a creatinine clearance rate of at least 50 mL/min.My prostate cancer was confirmed through a biopsy.My blood pressure is higher than 160/100 despite treatment.I am scheduled for a major prostate surgery at UCSF within 3 months after a special MRI.I have had treatments like cryosurgery or radiotherapy for prostate cancer but not TURP.I am unable to give informed consent due to a medical or psychiatric condition.I have heart issues like heart failure, recent heart attack, or specific EKG problems but controlled atrial fibrillation is okay.My liver is working well.I am taking medication for fluid build-up or eye pressure.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.My kidneys are working well.I cannot have gadolinium contrast due to health reasons.My bone marrow is working well.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-surgical participants with prostate cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the opportunity to volunteer for this clinical experiment still accessible?
"The information available on clinicaltrials.gov states that this medical trial is no longer seeking patients, having been initially posted in August of 2023 and lastly updated in May of the same year. However, there are a wealth of other trials still looking for volunteers at present with 1334 studies actively recruiting participants."
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