Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.

• Conditions: Prostate Neoplasm; Prostate Cancer
• Interventions: Diagnostic Test: VERDICT MRI; Diagnostic Test: Luminal Index Imaging

• Registration Number: NCT04792138
• Lead Sponsor: University College, London

Brief Summary

Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required.

This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-23
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10
• Primary Completion: 2022-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

• Men aged 18-90 with a clinical suspicion of prostate cancer
• No contraindication to MRI

Exclusion Criteria

• Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
• Men unable to given informed consent
• Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
• Ongoing hormonal treatment for prostate cancer

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men suspected of Prostate Cancer	VERDICT MRI	-
Men suspected of Prostate Cancer	Luminal Index Imaging	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of VERDICT MRI	2 years	Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone
Diagnostic accuracy of Luminal Water Imaging (LWI)	2 years	Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone

Secondary Outcome Measures

Name	Time	Method
The proportions of true positives with index tests is the same as mpMRI.	2 years

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom