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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within three years post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CTCAE v4.0 higher than grade 2
Secondary outcome measures
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

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
688 Previous Clinical Trials
374,636 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this experimental research at the moment?

"Affirmative. According to the clinicaltrials.gov listing, this study is still actively seeking patients since its inception on December 1st 2020 and most recent update on March 17th 2022. The trial requires 20 participants from a single medical site."

Answered by AI

To whom is enrollment in this research project open?

"This medical trial is in search of 20 prostate cancer patients aged 40 to 80 years. To be eligible, applicants need to plan on undergoing a MRI targeted biopsy or radical prostatectomy for their cancer workup/treatment; have a PSA > 4ng/ml, Abnormal DRE exam and known tissue diagnosis from prior testing."

Answered by AI

Is the trial open to participants who are in their golden years?

"To be eligible for this medical study, participants must be aged between 40 to 80 years. There are 76 trials intended for those younger than 40 and 1315 studies available for elderly individuals."

Answered by AI

How many people are partaking in this clinical research?

"Affirmative. The information accessible on clinicaltrials.gov states that this trial is presently accepting new enrollees. It was first announced in December of 2020 and the most recent update was made March 17th, 2022; seeking 20 participants from a single location."

Answered by AI

Can you provide assurance of the security of Hyperpolarized 13C-Pyruvate for patients?

"Although there is evidence that hyperpolarized 13C-pyruvate poses no safety risk, as this is a Phase 2 trial with limited data supporting efficacy, the score was assessed to be a 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
2020. "Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04698564.
~4 spots leftby Feb 2025
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