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Back|NCT06262139Recruiting
Official Title

An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients

Phase
Phase 1/Phase 2
Sponsor
Songqi Gao
Enrollment
12
Timeline
Jul 2024 → Dec 2026
About This Study

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

  • 1Male subjects aged \>18 years.
  • 2Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy.
  • 3Ability to lie still for MRI scanning.
  • 4Patients must be able to provide written informed consent.
  • 5Glomerular filtration rate (GFR) \> 60 mL/min within a 30 days of the research MRI.

Exclusion Criteria

  • 1Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease.
  • 2Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections.
  • 3Patients with uncontrolled diabetes or hypertension.
  • 4Patients with active non-prostate malignancy.
  • 5Patients with contraindications for MRI including implantable pace makers, cochlear implants.
  • 6Patients with uni- or bilateral hip prosthesis.
  • 7Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments.
  • 8Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy.
  • 9Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result.
  • 10Subjects 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.
  • 11Is determined by the investigator that the patient is clinically unsuitable for the study.
  • 12Is incapable of understanding the language in which the information for the patient is given.
  • 13Participation in a concurrent clinical trial or in another trial within the past 30 days.

Locations

1 site participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →