1. Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer
- Author
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Saurabh Singh, Manju Mathew, Thomy Mertzanidou, Shipra Suman, Joey Clemente, Adam Retter, Marianthi-Vasiliki Papoutsaki, Lorna Smith, Francesco Grussu, Veeru Kasivisvanathan, Alistair Grey, Eoin Dinneen, Greg Shaw, Martyn Carter, Dominic Patel, Caroline M Moore, David Atkinson, Eleftheria Panagiotaki, Aiman Haider, Alex Freeman, Daniel Alexander, Shonit Punwani, Institut Català de la Salut, [Singh S, Clemente J, Retter A] Centre for Medical Imaging, University College London, London, UK. [Mathew M] Centre for Medical Imaging, University College London, London, UK. Department of Pathology, University College London Hospitals NHS Foundation Trust, London, UK. [Mertzanidou T] Centre for Medical Imaging Computing, Department of Computer Science, University College London, London, UK. [Suman S] Centre for Medical Imaging, University College London, London, UK. Centre for Medical Imaging Computing, Department of Computer Science, University College London, London, UK. [Grussu F] Centre for Medical Imaging Computing, Department of Computer Science, University College London, London, UK. Grup de Radiòmica, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
Image-Guided Biopsy ,Male ,Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms [DISEASES] ,Pròstata - Càncer - Imatgeria per ressonància magnètica ,Càncer - Propensió ,Prostatic Neoplasms ,Otros calificadores::Otros calificadores::/diagnóstico por imagen [Otros calificadores] ,General Medicine ,Magnetic Resonance Imaging ,Biological Factors::Biomarkers [CHEMICALS AND DRUGS] ,factores biológicos::biomarcadores [COMPUESTOS QUÍMICOS Y DROGAS] ,neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata [ENFERMEDADES] ,Humans ,Prospective Studies ,Multiparametric Magnetic Resonance Imaging ,Biomarkers ,Other subheadings::Other subheadings::/diagnostic imaging [Other subheadings] - Abstract
IntroductionMultiparametric MRI (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. However, the technique has modest specificity and a high false-positive rate, especially in men with mpMRI scored as indeterminate (3/5) or likely (4/5) to have clinically significant cancer (csPCa) (Gleason ≥3+4). Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively. Before these techniques are translated clinically, robust histological and clinical validation is required.Methods and analysisThis study aims to clinically validate two advanced MRI techniques in a prospectively recruited cohort of men suspected of prostate cancer. Histological analysis of men undergoing biopsy or prostatectomy will be used for biological validation of biomarkers derived from Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging. In particular, prostatectomy specimens will be processed using three-dimension printed patient-specific moulds to allow for accurate MRI and histology mapping. The index tests will be compared with the histological reference standard to derive false positive rate and true positive rate for men with mpMRI scores which are indeterminate (3/5) or likely (4/5) to have clinically significant prostate cancer (csPCa). Histopathological validation from both biopsy and prostatectomy samples will provide the best ground truth in validating promising MRI techniques which could predict biopsy results and help avoid unnecessary biopsies in men suspected of prostate cancer.Ethics and disseminationEthical approval was granted by the London—Queen Square Research Ethics Committee (19/LO/1803) on 23 January 2020. Results from the study will be presented at conferences and submitted to peer-reviewed journals for publication. Results will also be available on ClinicalTrials.gov.Trial registration numberNCT04792138.
- Published
- 2022