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Hyperpolarized 13C-Pyruvate MRI for Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Robert Bok, 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 6 months
Awards & highlights
Study Summary
This trial studies how MRI imaging can measure how well cancer treatments are working. It pairs imaging with standard and investigational therapies.
Who is the study for?
This trial is for adults with advanced solid tumors who can follow the study plan and have signed consent. They should be fairly active (ECOG 0 or 1), have a tumor at least 1 cm big that's visible on scans, and good kidney function. Pregnant women, those with certain heart conditions, uncontrolled high blood pressure, or metal implants affecting MRI quality cannot join.Check my eligibility
What is being tested?
The study tests how well hyperpolarized 13C-Pyruvate works as an imaging biomarker when paired with standard cancer treatments or investigational therapies. It involves using metabolic MR imaging to track tumor metabolism in patients receiving these treatments.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than drug effects, side effects are minimal but may include discomfort from lying still during the MRI scan and potential risks associated with contrast agents used for imaging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean percent change from baseline in intratumoral HP pyruvate/lactate ratio
Signal-to-noise ratio (Part A)
Secondary outcome measures
Clinical benefit rate (CBR) (Part B)
Lactate/pyruvate ratio (Part B)
Median percent change from baseline in peak intratumoral hyperpolarized lactate-to-pyruvate ratio (Part B)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part B/ Phase II: Biomarker CohortExperimental Treatment2 Interventions
Participants will undergo paired hyperpolarized pyruvate/metabolic MR imaging at baseline and again after approximately 21 days of the participants SOC or investigational therapy outside of this protocol.
Group II: Part A / Phase 1: Feasibility Run-InExperimental Treatment2 Interventions
Participants will undergo MR imaging at a single time point. Imaging will take one day. and no follow up is planned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,930,491 Total Patients Enrolled
Sigma-AldrichUNKNOWN
1 Previous Clinical Trials
300 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I am 18 years old or older.I am set to receive either standard treatment or a trial drug for my condition.I haven't had a heart attack or major heart issues in the last 6 months.I have a tumor larger than 1.0 cm that can be imaged with a special MRI.I am unable to give informed consent due to my age, health, or mental condition.My blood pressure is higher than 160/100 mm Hg, but I can take medication to control it.I have heart failure or my condition limits my physical activity.My kidney function is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Part B/ Phase II: Biomarker Cohort
- Group 2: Part A / Phase 1: Feasibility Run-In
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.
What aim is this clinical trial attempting to reach?
"This trial seeks to determine the mean percentage change from baseline in intratumoral HP pyruvate/lactate ratio over a single day. Secondary objectives include gauging radiographic progression-free survival (rPFS), intra-patient reproducibility of HP lactate/pyruvate ratio, and quantifying adverse events among those who receive doses of HP 13C pyruvate."
Answered by AI
Are there vacancies available for participants in this research program?
"As per information available on clinicaltrials.gov, this trial is not enrolling patients at the moment. This study was first published on December 31st 2022 and last edited on October 25th 2022; however, there are 2,503 other medical trials currently recruiting applicants."
Answered by AI
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