Histo-MRI: Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Men suspected of Prostate Cancer
|
Diagnostic Test: VERDICT MRI
Advanced Diffusion Model
Diagnostic Test: Luminal Index Imaging
Advanced T2 mapping
|
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy of VERDICT MRI [2 years]
Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone
- Diagnostic accuracy of Luminal Water Imaging (LWI) [2 years]
Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone
Secondary Outcome Measures
- The proportions of true positives with index tests is the same as mpMRI. [2 years]
Other Outcome Measures
- Machine learning algorithms can predict histology from MRI. [3 years]
Number of correct predictions of gleason grade in men who undergo biopsy or prostatectomy.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University College London Hospital | London | United Kingdom |
Sponsors and Collaborators
- University College, London
Investigators
- Principal Investigator: Shonit Punwani, University College, London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 251440