An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients
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.
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.
Arms & interventions
- DrugMT218 injection
a targeted magnetic resonance imaging contrast agent
Outcome measures
Primary
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
Gleason scoring is the most common prostate cancer grading system. A Gleason score of 6 is a low-grade cancer. A Gleason score of 7 is a medium-grade cancer, and a score of 8, 9 or 10 is a high-grade cancer. mpMRI: multi-parametric MRI; PSMA-PET/CT: prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) and Computed Tomography (CT) scan
Time frame: up to 3 days after injection
Eligibility criteria
Study locations (1)
Emory University
Atlanta, Georgia, 30322