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

NCT06262139 · Molecular Theranostics LLC
In plain English

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Official title
An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients
About this study
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.
Eligibility criteria
Inclusion criteria * 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. Key exclusion criteria * Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease. * Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections. * Patients with uncontrolled diabetes or hypertension. * Patients with active non-prostate malignancy. * Patients with contraindications for MRI including implantable pace makers, cochlear implants. * Patients with uni- or bilateral hip prosthesis. * Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments. * Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy. * Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result. * Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection. * Is determined by the investigator that the patient is clinically unsuitable for the study. * Is incapable of understanding the language in which the information for the patient is given. * Participation in a concurrent clinical trial or in another trial within the past 30 days.
Study design
Enrollment target: 12 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-25
Estimated completion: 2026-12
Last updated: 2025-12-19
Interventions
Drug: MT218 injection
Primary outcomes
  • 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 (up to 3 days after injection)
Sponsor
Songqi Gao · industry
With: Emory University
Contacts & investigators
ContactDavid M Schuster, MD · contact · dschust@emory.edu · (404)712-4859
InvestigatorDavid Schuster, MD · principal_investigator, Emory University
All locations (1)
Emory UniversityRecruiting
Atlanta, Georgia, United States
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients · TrialPath