Recruiting
Phase 1
Phase 2

MRI Contrast Agent

Sponsor:

Songqi Gao

Code:

NCT06262139

Conditions

MRI Scan

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MT218 injection

Study Details

Brief summary:

This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy.

Conditions

MRI Scan

Study ID

NCT06262139

Start date

Jul 25, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MT218

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.

Interventions

MT218 injection

a targeted magnetic resonance imaging contrast agent

Primary outcome measure

  • 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 [ Time Frame: up to 3 days after injection ]

Central Contacts and Locations

Central contacts

David M Schuster, MD

(404)712-4859dschust@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Songqi Gao

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • MT218
  • target GBCA
  • peptide
  • MRI contrast agent
  • prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Songqi Gao on 2025-12-19.