Clinical trial · Interventional
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
NCT06262139CI-TRIAL-00099304recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MRI Scan | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MT218 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MT218
- description
- Each patient will receive a single intravenous injection of MT218 while being scanned with standard MR imaging sequences/protocol. The first cohort of four subjects will receive 0.02 mmol/kg, second cohort of four subjects will receive 0.04 mmol/kg, and third cohort of four subjects will receive 0.06 mmol/kg of MT218.
- interventionNames
- Drug: MT218 injection
Primary outcomes (1)
- measure
- Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT
- timeFrame
- up to 3 days after injection
- description
- Gleason scoring is the most common prostate cancer grading system. A Gleason score of 6 is a low-grade cancer. A Gleason score of 7 is a medium-grade cancer, and a score of 8, 9 or 10 is a high-grade cancer. mpMRI: multi-parametric MRI; PSMA-PET/CT: prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) and Computed Tomography (CT) scan
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.