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Recruiting NCT06262139

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

Phase I / Phase II Interventional MRI Scan

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MT218 injection.
Who it may be relevant to
Registry conditions: MRI Scan. Basic parameters: 18 years — 90 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Phase 1b open label, single-arm, dose-escalating investigation of safety and efficacy of a gadolinium (Gd) and peptide based MRI contrast agent (MT218) as an extradomain-B fibronectin (EDB-FN) targeted molecular MR contrast agent to detect aggressive prostate cancer with comparison of its results with the standard-of-care mutliparametic MRI (mpMRI) and PSMA PET/CT and histopathology validation in preprostatectomy patients diagnosed with prostate cancer in their clinical care.

Interventions

  • Drug MT218 injection
    a targeted magnetic resonance imaging contrast agent

Primary outcome 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/CT [Time frame: up to 3 days after injection]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Emory University — Atlanta

Identifiers

NCT: NCT06262139 · MT218-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗