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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~within three years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within three years post treatment for reporting.

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

Hyperpolarized 13C-Pyruvate (Metabolic Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04698564 — Phase 2
Prostate Cancer Research Study Groups: Single-arm study in patients who are suspected or known to have prostate cancer
Prostate Cancer Clinical Trial 2023: Hyperpolarized 13C-Pyruvate Highlights & Side Effects. Trial Name: NCT04698564 — Phase 2
Hyperpolarized 13C-Pyruvate (Metabolic Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04698564 — Phase 2
~4 spots leftby Dec 2025