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New MRI dye aims to sharpen detection of dangerous prostate cancers

NCT ID NCT06262139

Diagnosis Sponsor: Songqi Gao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing a new MRI contrast agent called MT218 that targets prostate cancer cells. The goal is to see if it can more clearly identify aggressive tumors (Gleason score 8-10) compared to standard MRI scans. The study will enroll 12 men scheduled for prostate removal surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT218 injection (a targeted MRI contrast agent)
What this could lead to
If successful, this could lead to a more accurate MRI scan that better identifies aggressive prostate cancers, potentially reducing unnecessary biopsies.
What could go wrong
This is a very early, small study (12 people) focused on safety and dosing. The contrast agent may not work as hoped, and results may not apply to all prostate cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mri scan

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States