Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis. (Histo-MRI)

Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Neoplasm
• Intervention / Treatment: Diagnostic test: VERDICT MRI; Diagnostic test: Luminal Index Imaging

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Joey Clemente; Phone Number: 07886178028; Email: j.clemente@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College London Hospital
    • Contact: Joey Clemente; Phone Number: 07886178028; Email: j.clemente@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Cohort of men presenting to our recruitment centre with suspicion of prostate cancer due to raised prostate specific antigen level or suspicious clinical examination.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men suspected of Prostate Cancer	Diagnostic test: VERDICT MRI; Advanced Diffusion Model; Diagnostic test: Luminal Index Imaging; Advanced T2 mapping

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportions of true positives with index tests is the same as mpMRI.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Machine learning algorithms can predict histology from MRI.	Number of correct predictions of gleason grade in men who undergo biopsy or prostatectomy.	3 years

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Shonit Punwani, University College, London

Publications and helpful links

General Publications

• Singh S, Mathew M, Mertzanidou T, Suman S, Clemente J, Retter A, Papoutsaki MV, Smith L, Grussu F, Kasivisvanathan V, Grey A, Dinneen E, Shaw G, Carter M, Patel D, Moore CM, Atkinson D, Panagiotaki E, Haider A, Freeman A, Alexander D, Punwani S. Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer. BMJ Open. 2022 Apr 8;12(4):e059847. doi: 10.1136/bmjopen-2021-059847.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2020
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Phenobarbital
• Other Study ID Numbers: 251440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No