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

NCT ID: NCT04792138

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-23

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Prostate Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Men suspected of Prostate Cancer

VERDICT MRI

Intervention Type DIAGNOSTIC_TEST

Advanced Diffusion Model

Luminal Index Imaging

Intervention Type DIAGNOSTIC_TEST

Advanced T2 mapping

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VERDICT MRI

Advanced Diffusion Model

Intervention Type DIAGNOSTIC_TEST

Luminal Index Imaging

Advanced T2 mapping

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College, London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shonit Punwani

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University College London Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Joey Clemente

Role: CONTACT

07886178028

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joey Clemente

Role: primary

07886178028

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35396316 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

251440

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prostate Imaging Using MRI +/- Contrast Enhancement
NCT04571840 ACTIVE_NOT_RECRUITING NA