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RecruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests different doses of MT218, an injected dye used to help MRI scans show prostate cancer. It is for men with confirmed prostate cancer who are scheduled for surgery to remove the prostate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men older than 18.
  • Prostate cancer with a Gleason score of 8–10, a rating that shows how abnormal the cancer cells look.
  • Have had at least one detailed prostate MRI scan and one prostate biopsy (a test that removes a small tissue sample).
  • Can lie still for an MRI scan.
  • Can give written consent to join the study.
  • Have a kidney filtering test result (GFR) above 60 mL/min within 30 days before the study MRI.

Who can't join

  • Have active kidney or liver disease, uncontrolled diabetes or high blood pressure, or active cancer other than prostate cancer.
  • Have sudden prostate inflammation, an enlarged prostate that causes symptoms or is severe, or a urinary tract infection.
  • Cannot safely have an MRI, including because of a pacemaker or an inner-ear hearing implant; or have one or two artificial hips.
  • Have another serious health problem that makes surgery too risky, makes it hard to stay in the study, or affects study tests; or the study doctor finds you unsuitable.
  • Had major surgery within 4 weeks before joining, have not recovered from its side effects, or had a prostate biopsy within 4 weeks that may cause inflammation affecting the MRI.
  • Receive another MRI dye within 48 hours before or 24 hours after the MT218 injection.
  • Cannot understand the language used in the study information.
  • Are in another clinical trial now or were in one within the past 30 days.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

GA