PRostate Cancer Enhanced Diagnosis by Calibration Technology
ConditionProstate Cancers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorGold Standard Phantoms
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Male participants with suspected prostate cancer residing in the London area.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
MRI
Diagnostic testStandard MRI using phantom.
Treatment groups
66 Participants
are divided into 1 treatment groupGroup A: Single Group Males1 intervention
Trial outcomes
Primary outcomes
1
Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners
To determine the reproducibility of GSP CARE reference phantom corrected lesion ADC measurements when the phantom is used on different MRI scanners for measurement of ADC in prostate. Voxel-wise median ADC values will be obtained for each lesion region of interest (ROI), referred to in the synopsis as "ADC measurements". The study is designed for 3 pairwise comparisons of 3 MRI scanners, enabling reproducibility determination between each pair of scanners. The study is powered for each pairwise comparison, based on a single lesion per patient.
Time frame
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.Secondary outcomes
1
Assessment of Reproducibility Between MRI Scanners
To determine whether increasing the between scanner reproducibility enables sufficiently precise voxelwise median ADC measurements (i.e. variance is not inferior to a minimally acceptable variance) to be able to distinguish between the expected ADC values from clinically significant and clinically insignificant prostate lesions.
Time frame
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.2
Observation of the Extent to Which Biopsy Can be Avoided when Using GSP CARE Phantom System
To investigate the proportion of men who would receive a correct clinical recommendation that biopsy could be avoided using ADC measurements with and without GSP CARE reference phantom correction. This is a feasibility analysis to indicate data needed to power a trial to demonstrate a difference in proportion. Data will be presented graphically, with 95% confidence intervals using Wilson method. The study is not powered to show a statistical significance. Comparison of paired proportions within patient of recommendations using ADC measurements with and without GSP CARE reference phantom correction.
Time frame
From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.3
Determination of Per-Lesion Diagnostic Accuracy of GSP CARE-Corrected ADC Measurements
To determine per-lesion diagnostic accuracy of ADC measurements, corrected using the GSP CARE reference phantom, for significant cancer in men scheduled for standard of care biopsy with Likert/PIRADS 3 or above scored MRI lesions. Sensitivity and specificity will be calculated per lesion, with 95% confidence intervals using Wilson method. Statistical significance will be based on 95% confidence intervals.
Time frame
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.4
Determination of the Association Between GSP CARE Reference Phantom Corrected Lesion ADC Measurements and Tumour Gleason Grade
Time frame
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gold Standard Phantoms
Lead sponsor
Bioxydyn Ltd, Manchester
Collaborator
National Cancer Imaging Translational Accelerator
Collaborator
University College London Hospitals
Collaborator
National Hospital for Neurology and Neurosurgery
Collaborator
Source ClinicalTrials.gov