Clinical trial NCT06607783: PRostate Cancer Enhanced Diagnosis by Calibration Technology
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancers
Keywords: MRI
Calibration
Prostate Cancer
Quantitative Imaging Biomarker
Reproducibility
Data interoperability
Phantom
Apparent Diffusion Coefficient
ADC
PIRAD
Diagnosis
Biopsy
Lead sponsor: Gold Standard Phantoms
Sponsor class: INDUSTRY
Collaborators: name: Bioxydyn Ltd, Manchester
name: National Cancer Imaging Translational Accelerator
name: University College London Hospitals
name: National Hospital of Neurology and Neurosurgery, Queens Square, London, UK
First posted: 2024-09-23
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male participants with suspected prostate cancer residing in the London area.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Men with clinically suspected prostate cancer and referred for prostate MRI
* Men willing and able to provide a written informed consent
* MRI Likert/PIRADS 3 or above
* Prior decision made to perform targeted biopsy

Exclusion Criteria:

* Prostate specific antigen (PSA) level \&amp;gt; 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

Primary outcomes:
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.
Secondary outcomes:
measure: Assessment of Reproducibility Between MRI Scanners
timeFrame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
measure: Determination of Per-Lesion Diagnostic Accuracy of GSP CARE-Corrected ADC Measurements
timeFrame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
measure: Observation of the Extent to Which Biopsy Can be Avoided when Using GSP CARE Phantom System
timeFrame: From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.
measure: Determination of the Association Between GSP CARE Reference Phantom Corrected Lesion ADC Measurements and Tumour Gleason Grade
timeFrame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
measure: Investigation of Device Usability
timeFrame: From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
References: