Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients
Recruiting
Phase 1Phase 2Interventional Study
MRI Scan
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Male
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
12 (estimated)
Sponsor
Songqi Gao · Industry
Who this trial is looking for
This trial is looking for men who have been diagnosed with aggressive prostate cancer and are scheduled for surgery. Participants will receive an injection of MT218 to help improve prostate MRI imaging.
Are You a Good Fit for This Trial?
You may be able to join if
I am a male over 18 years old.
I have been diagnosed with prostate cancer with a Gleason score of 8 to 10.
I have had a prostate MRI and biopsy.
I can lie still for an MRI scan.
I can provide written consent.
My kidney function is good (GFR > 60 mL/min).
You may not be able to join if
I have active kidney or liver disease.
I have had acute prostatitis or severe urinary issues.
I have uncontrolled diabetes or high blood pressure.
I have another type of cancer.
I have a pacemaker or any device that is not safe for an MRI.
I have hip implants.
I had major surgery in the last 4 weeks.
I had a prostate biopsy in the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 filtrati…
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.
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