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

Active:	Yes
Cancer Type:	Prostate Cancer	NCT ID:	NCT06262139
Trial Phases:	Phase I Phase II	Protocol IDs:	MT218-002 (primary) NCI-2024-04399
Eligibility:	18 - 90 Years, Male	Study Type:	Diagnostic
Study Sponsor:	Molecular Theranostics LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT06262139

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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