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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within three years post treatment

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

0 / 2Eligibility criteria met