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

University College London (UCL)

Status: Unknown

Conditions: Prostate Neoplasm; Prostate Cancer

Treatments: Diagnostic Test: Luminal Index Imaging; Diagnostic Test: VERDICT MRI

Study type: Observational

Funder types: Other

Identifiers

NCT04792138

251440

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300 participants in 1 patient group

Men suspected of Prostate Cancer

Treatment:

Diagnostic Test: VERDICT MRI

Diagnostic Test: Luminal Index Imaging