An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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.
Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Contact Information
Primary
David M Schuster, MD
dschust@emory.edu
(404)712-4859
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University
Leads: Songqi Gao