PRostate Cancer Enhanced Diagnosis by Calibration Technology
NCT ID: NCT06607783
Last Updated: 2025-08-28
Study Results
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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NOT_YET_RECRUITING
66 participants
OBSERVATIONAL
2025-09-30
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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
Standard MRI using phantom.
Interventions
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MRI
Standard MRI using phantom.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Bioxydyn Ltd, Manchester
UNKNOWN
National Cancer Imaging Translational Accelerator
UNKNOWN
University College London Hospitals
OTHER
National Hospital of Neurology and Neurosurgery, Queens Square, London, UK
UNKNOWN
Gold Standard Phantoms
INDUSTRY
Responsible Party
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Locations
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University College Hospital
London, London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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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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