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

Prostate Cancer Clinical Trial

— Histo-MRI  

Official title:

Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792138
• Other study ID #: 251440
• Status: Recruiting
• Start date: October 23, 2020
• Est. completion date: October 2023

Study information

• Verified date: March 2021
• Source: University College, London
• Contact: Joey Clemente
• Phone: 07886178028
• Email: j.clemente[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• VERDICT MRI
Advanced Diffusion Model
• Luminal Index Imaging
Advanced T2 mapping

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Machine learning algorithms can predict histology from MRI.	Number of correct predictions of gleason grade in men who undergo biopsy or prostatectomy.	3 years
Primary	Diagnostic accuracy of VERDICT MRI	Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone	2 years
Primary	Diagnostic accuracy of Luminal Water Imaging (LWI)	Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone	2 years
Secondary	The proportions of true positives with index tests is the same as mpMRI.		2 years