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PRostate Cancer Enhanced Diagnosis by Calibration Technology

NCT06607783 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2025-08-28

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

MRI

Standard MRI using phantom.

Sponsors & Collaborators

  • Bioxydyn Ltd, Manchester

    collaborator UNKNOWN

  • National Cancer Imaging Translational Accelerator

    collaborator UNKNOWN

  • University College London Hospitals

    collaborator OTHER

  • National Hospital of Neurology and Neurosurgery, Queens Square, London, UK

    collaborator UNKNOWN

  • Gold Standard Phantoms

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607783 on ClinicalTrials.gov