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Clinical Trials in the USA / NCT06262139
Recruiting Phase 1/2

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

NCT06262139 · tracked via the Priya Life Science USA tracker
Sponsor
Songqi Gao
Phase
Phase 1/2
Started
2024-07-25
Last updated
2025-12-19

Condition(s) studied

MRI Scan

Investigational drug(s) / intervention(s)

MT218 injection

MT218 injection: a targeted magnetic resonance imaging contrast agent

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Emory University Atlanta Georgia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06262139 on ClinicalTrials.gov ↗ ← All trials in the USA