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Metabolic Imaging Agent
Hyperpolarized MRI for Prostate Cancer
Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 40 and less than 80 years
Be older than 18 years old
Must not have
Inability to receive IV contrast as per institutional protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within three years post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial will use magnetic resonance imaging to study whether or not it is safe to use on men with prostate cancer.
Who is the study for?
This trial is for men aged 40-80 who may have prostate cancer, indicated by a PSA level over 4ng/ml, an abnormal DRE exam, or a known diagnosis from previous tests. Participants should be planning to undergo a biopsy or surgery for prostate cancer.
What is being tested?
The study is testing the use of metabolic MRI using Hyperpolarized 13C-Pyruvate on men suspected of having prostate cancer. It aims to determine if this type of advanced imaging can be done safely in these patients.
What are the potential side effects?
Since there's no drug being tested and it's an imaging technique, side effects are minimal but may include discomfort from lying still during the MRI and potential reactions to IV contrast used in standard MRIs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 41 and 79 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have IV contrast due to hospital rules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within three years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within three years post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CTCAE v4.0 higher than grade 2
Secondary study objectives
Accuracy of metabolic MRI to diagnose prostate cancer
Correlative metabolic analysis of tissue metabolite concentrations versus cancer diagnosis
Utility of metabolic MRI over standard MRI imaging in the diagnosis of prostate cancer
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-arm study in patients who are suspected or known to have prostate cancerExperimental Treatment1 Intervention
Perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,109 Total Patients Enrolled
12 Trials studying Prostate Cancer
579 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have IV contrast due to hospital rules.I have signs of prostate cancer, such as a high PSA level, an abnormal exam, or a known diagnosis.I am between 41 and 79 years old.You cannot have an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm study in patients who are suspected or known to have 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.