Your session is about to expire
← Back to Search
Hyperpolarized C 13 Pyruvate MRI for Prostate Cancer
Phase 2
Waitlist Available
Led By Vikas Kundra
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gleason >= 8 OR Gleason 7 + >= cT2b + prostate specific antigen (PSA) > 10 ng/ml
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial uses magnetic resonance spectroscopic imaging to study how well prostate cancer patients will respond to standard therapy.
Who is the study for?
Men with high-risk prostate cancer, either newly diagnosed or untreated metastatic, are eligible. They must have a Gleason score of at least 7 if cT2b and PSA >10 ng/ml, or a score of 8 or higher. Recent hormone therapy is okay if started within the last month. Men can't join if they're allergic to MRI contrast gadavist, have severe kidney issues (eGFR <30), contraindications to MRI scans, or a history of heart rhythm problems.Check my eligibility
What is being tested?
The trial is testing how well a special type of imaging called hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging predicts treatment outcomes in men with prostate cancer when using standard therapies like abiraterone and apalutamide.See study design
What are the potential side effects?
While this trial focuses on imaging techniques rather than drug side effects, potential risks may include reactions to the contrast agent used for MRI (gadavist), discomfort from lying still during the scan, and loud noises from the MRI machine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is aggressive based on Gleason score or PSA levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reproducibility of the key performance indicator
Secondary outcome measures
Sensitivity assessed by comparison to biopsy
Specificity assessed by comparison to biopsy
Side effects data
From 2019 Phase 1 trial • 9 Patients • NCT0356536733%
Anosmia
33%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteers
Known CNS Malignancy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)Experimental Treatment2 Interventions
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperpolarized Carbon C 13 Pyruvate
2018
Completed Phase 1
~10
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,779 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,151 Total Patients Enrolled
Vikas KundraPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
416 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of irregular heartbeats.I am not a woman, so pregnancy is not applicable.I am allergic to gadavist contrast dye.I have high-risk or untreated metastatic prostate cancer, but may have started hormone therapy recently.My prostate cancer is aggressive based on Gleason score or PSA levels.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
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 are the potential risks associated with Hyperpolarized Carbon C 13 Pyruvate?
"While there is some evidence of Hyperpolarized Carbon C 13 Pyruvate's safety, it is still classified as a Phase 2 drug due to the lack of clinical data supporting its efficacy."
Answered by AI
Are medical professionals currently enrolling patients in this trial?
"According to the latest information on clinicaltrials.gov, this particular medical trial is not looking for any more patients at the present time. This study was originally posted on February 6th, 2019 but has since been closed to recruitment as of November 16th, 2020. Although this research is no longer enrolling participants, there are 1,315 other trials that are still open and recruiting patients across a variety of conditions."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger