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Targeted Contrast Agent

MT218 Injection for Prostate Cancer

Phase 1 & 2

Recruiting

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

Must not have

Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease

Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 days after injection

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active kidney or liver disease.

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I have had recent severe prostate issues or urinary infections.

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My diabetes or blood pressure is not well-controlled.

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I have an active cancer that is not prostate cancer.

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I haven't had major surgery in the last 4 weeks or still recovering from one.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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: 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 / 9Eligibility criteria met