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Targeted Contrast Agent

MT218 for Magnetic Resonance Imaging

Phase 1 & 2

Waitlist Available

Led By David Schuster, MD

Research Sponsored by Molecular Theranostics LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Glomerular filtration rate (GFR) > 60 mL/min within a 30 days of the research MRI

Male subjects aged >18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 days after injection

Awards & highlights

Study Summary

This trial aims to test the effectiveness of using a new injection called MT218 to help improve imaging of prostate cancer in patients before surgery.

Who is the study for?

This trial is for men with prostate cancer who are scheduled to have their prostate removed. It's an early-phase study, so they're looking for people who haven't had this kind of imaging before.Check my eligibility

What is being tested?

The study tests different doses of a new MRI contrast agent called MT218 to see how well it shows prostate cancer on scans. This is done just before patients have surgery to remove the prostate.See study design

What are the potential side effects?

Since this summary doesn't provide specific side effects, we can say: 'Potential side effects are not detailed here but may include reactions at the injection site or changes in body response due to the contrast agent.'

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good, with a GFR over 60 mL/min.

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I am a man older than 18.

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My prostate cancer has a high Gleason score and I've had an MRI and biopsy.

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I can stay still for an MRI scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 days after injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 days after injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 days after injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT

Trial Design

1Treatment groups

Experimental Treatment

Group I: MT218Experimental Treatment1 Intervention

Each patient will receive a single intravenous injection of MT218 while being scanned with standard MR imaging sequences/protocol. The first cohort of four subjects will receive 0.02 mmol/kg, second cohort of four subjects will receive 0.04 mmol/kg, and third cohort of four subjects will receive 0.06 mmol/kg of MT218.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityOTHER

1,640 Previous Clinical Trials

2,560,645 Total Patients Enrolled

Molecular Theranostics LLCLead Sponsor

David Schuster, MDPrincipal InvestigatorEmory University

3 Previous Clinical Trials

37 Total Patients Enrolled

Frequently Asked Questions

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

Is it possible for individuals to participate in this clinical trial?

"Candidates must have magnetic resonance imaging and be aged between 18 and 90 to qualify for this research study. A total of 12 participants will be enrolled in the trial."

Answered by AI

Are patients currently able to participate in this ongoing research study?

"As per clinicaltrials.gov, the current trial is not in the recruitment phase. It was initiated on March 1st, 2024, with the most recent update made on February 8th of the same year. While this specific study is no longer accepting participants, there are currently 1260 alternative trials actively seeking candidates for enrollment."

Answered by AI

Are participants who are older than 40 years of age eligible for enrollment in this research study?

"Participants must be aged between 18 and 90 to qualify for this study. Notably, there are 65 trials available for those under 18 years old and 1258 studies catering to individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients

2024. "Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06262139.