NCT06262139RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 23 Jan 2024
- Start date
- Jul 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Songqi Gao
- Diseases
- Prostate cancer
- NCT number
- NCT06262139
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From Jul 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications for MRI including implantable pace makers, cochlear implants.
- 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.
- Participation in a concurrent clinical trial or in another trial within the past 30 days.
Other illness
- 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.
- Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments.
Other
- Patients with uni- or bilateral hip prosthesis.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.