Actively Recruiting
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients
Led by Songqi Gao · Updated on 2025-12-19
12
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
S
Songqi Gao
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged >18 years
- Confirmed Gleason score of 8 to 10 prostate cancer
- At least one prostate multiparametric MRI and one prostate biopsy completed
- Ability to lie still during MRI scanning
- Ability to provide written informed consent
- Glomerular filtration rate (GFR) greater than 60 mL/min within 30 days before the research MRI
You will not qualify if you...
- Active acute, chronic, or sub-chronic kidney or liver disease
- Acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH), or urinary tract infections
- Uncontrolled diabetes or hypertension
- Active non-prostate cancer malignancy
- Contraindications for MRI such as implantable pacemakers or cochlear implants
- Presence of uni- or bilateral hip prosthesis
- Significant medical conditions posing unacceptable operative risk or affecting study participation
- Major surgery within 4 weeks before study entry or incomplete recovery from such surgery
- Prostate biopsy within 4 weeks before study entry that may affect MRI results
- Receipt of any MRI contrast agent within 48 hours before or up to 24 hours after MT218 injection
- Investigator-determined clinical unsuitability for the study
- Inability to understand the patient information language
- Participation in another clinical trial within the past 30 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
D
David M Schuster, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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