Using a new MRI contrast agent to improve prostate cancer imaging

An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients

This study is testing a new MRI contrast agent to see if it can better detect aggressive prostate cancer in patients who are about to have surgery.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 90 Years
• Sex: Male
• Sponsor: Molecular Theranostics LLC (industry)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT06262139 on ClinicalTrials.gov

What this trial studies

This phase 1b open label, dose-escalating study evaluates the safety and efficacy of a gadolinium and peptide-based MRI contrast agent, MT218, for detecting aggressive prostate cancer in patients scheduled for radical prostatectomy. The study compares the results of MT218 with standard multiparametric MRI and PSMA PET/CT imaging, along with histopathology validation. The goal is to determine the initial effectiveness of this targeted imaging approach in identifying high-grade prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are male patients over 18 years old with a confirmed Gleason score of 8-10 prostate cancer who have undergone at least one mpMRI and one biopsy.

Not a fit: Patients with active kidney or liver disease, uncontrolled diabetes or hypertension, or those with contraindications for MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging techniques for better detection and characterization of aggressive prostate cancer.

How similar studies have performed: Other studies have shown promise with targeted imaging agents, but this specific approach using MT218 is novel.

Eligibility criteria

Inclusion criteria

* 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.

Key exclusion criteria

* 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.

Where this trial is running

Atlanta, Georgia

• Emory University — Atlanta, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: David Schuster, MD — Emory University
• Study coordinator: David M Schuster, MD

Conditions: MRI Scan, MT218, target GBCA, peptide, MRI contrast agent, prostate cancer