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Evaluating MT218 for Prostate Cancer Detection

This study is testing a new type of MRI contrast agent called MT218. This agent is designed to help doctors better see aggressive prostate cancer (Gleason score 8 to 10) during an MRI scan. Researchers will compare how well MT218 works against standard MRI contrast agents and PSMA-PET/CT scans. To join, you must be a man aged 18 to 90 with confirmed aggressive prostate cancer and have had previous MRI and biopsy. You also need to be able to lie still for an MRI and have good kidney function. The study aims to see if MT218 can effectively detect these cancers. The current recruitment status is unclear.

Study design
This is a Phase 1b, open-label, single-arm study with 12 planned participants. It will test different doses of MT218.
What's involved
You would receive an MT218 injection and undergo an MRI scan. The primary endpoint is measured up to 3 days after the injection.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 3 days after injection, but longer-term follow-up is not specified.

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NCT06262139

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

Recruiting
PHASE1Ages 18–90InterventionalDiagnostic
Songqi Gao
~12 participants
Updated 2025-12-19 on ClinicalTrials.gov
What's tested:MT218 injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over up to 3 days after injection

Conditions

MRI Scan

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • David Schuster, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

David M Schuster, MD
[email protected]
(404)712-4859
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male subjects aged \>18 years.
Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy.
Ability to lie still for MRI scanning.
Patients must be able to provide written informed consent.
Glomerular filtration rate (GFR) \> 60 mL/min within a 30 days of the research MRI.

Exclusion

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.
Patients with uncontrolled diabetes or hypertension.
Patients with active non-prostate malignancy.
Patients with contraindications for MRI including implantable pace makers, cochlear implants.
Patients with uni- or bilateral hip prosthesis.
Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments.
Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy.
Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result.
Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection.
Is determined by the investigator that the patient is clinically unsuitable for the study.
Is incapable of understanding the language in which the information for the patient is given.
Participation in a concurrent clinical trial or in another trial within the past 30 days.

What this trial 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/CTup to 3 days after injection

    Gleason scoring is the most common prostate cancer grading system. A Gleason score of 6 is a low-grade cancer. A Gleason score of 7 is a medium-grade cancer, and a score of 8, 9 or 10 is a high-grade cancer. mpMRI: multi-parametric MRI; PSMA-PET/CT: prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) and Computed Tomography (CT) scan