Using a new MRI contrast agent to improve prostate cancer imaging
Official title: An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients
Run by Molecular Theranostics LLC · NCT06262139 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 90 Years |
| Sex | Men only |
| Enrollment | 12 (estimated) |
| Sponsor | Molecular Theranostics LLC Industry-sponsored |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | July 25, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT06262139 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with targeted imaging agents, but this specific approach using MT218 is novel.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Emory University
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: David Schuster, MD — Emory University
- Study coordinator: David M Schuster, MD
- Email: dschust@emory.edu
- Phone: (404)712-4859
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.