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

Conditions

• MRI Scan

Eligibility Criteria

Sex

MALE

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• MT218 injection — DRUG
  a targeted magnetic resonance imaging contrast agent

Study Details

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.

Key Dates

Start date

Jul 25, 2024

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

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.

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

• David M Schuster, MD
  (404)712-4859
  [email protected]

Locations (1)

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