NCT06262139 Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients
| NCT ID | NCT06262139 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Songqi Gao |
| Condition | MRI Scan |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-07-25 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
David Schuster, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT06262139 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 90 Years, studying MRI Scan. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06262139 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06262139 currently recruiting?
Yes, NCT06262139 is actively recruiting participants. Contact the research team at dschust@emory.edu for enrollment information.
Where is the NCT06262139 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT06262139 clinical trial?
NCT06262139 is sponsored by Songqi Gao. The principal investigator is David Schuster, MD at Emory University. The trial plans to enroll 12 participants.