Clinical trial NCT04792138: Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.
Official title: Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Prostate Neoplasm
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Diagnostic accuracy of VERDICT MRI
timeFrame: 2 years
measure: Diagnostic accuracy of Luminal Water Imaging (LWI)
timeFrame: 2 years
Secondary outcomes:
measure: The proportions of true positives with index tests is the same as mpMRI.
timeFrame: 2 years
Other outcomes:
measure: Machine learning algorithms can predict histology from MRI.
timeFrame: 3 years
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: University College, London
name: Shonit Punwani
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.