Clinical trial · Observational
PRostate Cancer Enhanced Diagnosis by Calibration Technology
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of patients undergoing a multi-parametric MRI (mpMRI) scan to detect prostate cancer. The final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (SaMD) for calibrating the resulting mpMRI images. In this clinical trial, patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis. The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.
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 |
|---|---|---|---|
| Prostate Cancers | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Group Males
- description
- Men with clinically suspected prostate cancer and referred for prostate MRI with Likert/PIRADS 3 or above and prior decision made to perform targeted biopsy.
- interventionNames
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners
- timeFrame
- From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
- description
- To determine the reproducibility of GSP CARE reference phantom corrected lesion ADC measurements when the phantom is used on different MRI scanners for measurement of ADC in prostate. Voxel-wise median ADC values will be obtained for each lesion region of interest (ROI), referred to in the synopsis as "ADC measurements". The study is designed for 3 pairwise comparisons of 3 MRI scanners, enabling reproducibility determination between each pair of scanners. The study is powered for each pairwise comparison, based on a single lesion per patient.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available