PRostate Cancer Enhanced Diagnosis by Calibration Technology

NCT ID: NCT06607783

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Group Males

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.

MRI

Intervention Type DIAGNOSTIC_TEST

Standard MRI using phantom.

Interventions

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MRI

Standard MRI using phantom.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bioxydyn Ltd, Manchester

UNKNOWN

Sponsor Role collaborator

National Cancer Imaging Translational Accelerator

UNKNOWN

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Gold Standard Phantoms

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University College Hospital

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Lucy Newton

Role: CONTACT

0044 7745627050

Facility Contacts

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Harbir Sidhu

Role: primary

0044 7946610486

Other Identifiers

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10071751

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

340447

Identifier Type: OTHER

Identifier Source: secondary_id

GSP001

Identifier Type: -

Identifier Source: org_study_id

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