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

Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients (NCT06262139) is a Phase 1 / Phase 2 interventional studying MRI Scan, sponsored by Songqi Gao. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For MRI Scan, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 12 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

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 willing to sign a consent form. - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

MT218 injection

a targeted magnetic resonance imaging contrast agent

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Emory University

Atlanta, Georgia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06262139), the sponsor (Songqi Gao), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06262139 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06262139?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06262139?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06262139. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06262139. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.