Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

a targeted magnetic resonance imaging contrast agent

MT218 injection

David M Schuster, MD

David Schuster, MD

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.

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.

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

An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients	NCT06262139	MRI Scan	MT218 injection	18 Years - 90 Years	Molecular Theranostics LLC
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients	NCT06262139	MRI Scan	MT218 injection	18 Years - 90 Years	Molecular Theranostics LLC

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