PRostate Cancer Enhanced Diagnosis by Calibration Technology

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест MRI
  Standard MRI using phantom.

Первичные конечные точки

• Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners [Срок оценки: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]

Вторичные конечные точки (5)

• Assessment of Reproducibility Between MRI Scanners [Срок оценки: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
• Observation of the Extent to Which Biopsy Can be Avoided when Using GSP CARE Phantom System [Срок оценки: From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.]
• Determination of Per-Lesion Diagnostic Accuracy of GSP CARE-Corrected ADC Measurements [Срок оценки: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
• Determination of the Association Between GSP CARE Reference Phantom Corrected Lesion ADC Measurements and Tumour Gleason Grade [Срок оценки: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
• Investigation of Device Usability [Срок оценки: From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Великобритания · 1 центр

• University College Hospital — London

Идентификаторы

NCT: NCT06607783 · GSP001 · 10071751 · 340447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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