Calibration-powered MRI for Prostate Cancer: Enhanced Diffusion Measurements
Official title: A Multi-Centre, Pivotal Stage, Study to Determine the Between MRI Scanner Reproducibility of Gold Standard Phantom Calibrated Acquisition Replicator (CARE) for Measurement of Apparent Diffusion Coefficients in the Prostate of Patients With MR Positive Lesions Destined for Biopsy
Run by Gold Standard Phantoms · NCT06607783 · Data updated 2026-11-12
This study tests whether the CARE Phantom system can improve the consistency of MRI-based diffusion measurements in men undergoing MRI for suspected prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 66 (estimated) |
| Sponsor | Gold Standard Phantoms Industry-sponsored |
| Locations | 1 site (London, London) |
| Status | Recruiting |
| Started | June 26, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06607783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men 18 years and older being investigated for prostate cancer with at least one lesion rated Likert 3 or higher on clinical reports and planning a targeted biopsy within 6 months.
✕Probably not a fit
Patients with PSA >20 ng/mL, prior prostate cancer, recent hormone therapy, or contraindications to MRI may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The CARE Phantom system includes a calibration mat with embedded phantoms, a docking station, and software for calibrating mpMRI images to enable reliable diffusion measurements in the prostate. Participants will have MRI scans across different scanners using GSP Phantoms to collect data for in silico analysis. The goal is to refine the SaMD calibration software and determine how reproducible the apparent diffusion coefficient (ADC) measurements are across sites and devices. This observational study uses standard clinical MRI as part of the imaging workflow and does not assign a new treatment.
Why it matters
Potential benefit: If successful, patients could benefit from more reliable MRI measurements that improve cancer detection and risk stratification.
How similar studies have gone: Prior studies with phantom calibration have shown promise in improving imaging reproducibility, but this approach is relatively novel in this specific calibration workflow.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men aged 18 years and older undergoing investigations for PCa. * Standard of Care MRI conducted. * One or more lesions with a Likert score of 3 or above identified on clinical reports. * Planned targeted biopsy within 6 months from the date of clinical care MRI. * Willing and able to provide written informed consent. Exclusion Criteria: * Prostate specific antigen (PSA) level \> 20ng/ml within 6 months * Previous diagnosis of prostate cancer * Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors * Contraindication to MRI scan
Where it's running
-
University College Hospital
London, London, United Kingdom Recruiting
Study contacts
- Study coordinator: Lucy Newton
- Email: lucy.newton@goldstandardphantoms.com
- Phone: 0044 7745627050
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.