PRostate Cancer Enhanced Diagnosis by Calibration Technology (PREDICT)

Gold Standard Phantoms

Status: Not yet enrolling

Conditions: Prostate Cancers

Treatments: Diagnostic Test: MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06607783

GSP001

340447 (Other Identifier)

10071751 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

66 participants in 1 patient group

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.

Treatment:

Diagnostic Test: MRI