Prostate CancerHisto-MRINCT04792138
Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.
An observational study of Prostate Cancer and Prostate Neoplasm, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm
- What is being tested?
- VERDICT MRI and Luminal Index Imaging
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2020to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men aged 18-90 with a clinical suspicion of prostate cancer
- No contraindication to MRI
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
Joey Clemente, 07886178028, j.clemente@nhs.net
About this study
Official title: Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis
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.
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Being tested
- VERDICT MRI, Luminal Index Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERDICT MRIDiagnostic test
Advanced Diffusion Model
Luminal Index ImagingDiagnostic test
Advanced T2 mapping
| Study group | Role | What they receive |
|---|---|---|
| Men suspected of Prostate Cancer | Not described Receives: Diagnostic Test: VERDICT MRI; Diagnostic Test: Luminal Index Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of VERDICT MRI
Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone
Measured: 2 years
Diagnostic accuracy of Luminal Water Imaging (LWI)
Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone
Measured: 2 years
Secondary outcomes (1)
The proportions of true positives with index tests is the same as mpMRI.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start23 Oct 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shonit Punwani, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792138
- Sponsor's protocol ID
- 251440
- Acronym
- Histo-MRI
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35396316
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis
- ClinicalTrials.gov ID
- NCT04792138
- Acronym / sponsor ID
- Histo-MRI / 251440
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men suspected of Prostate Cancer | – | Diagnostic Test: VERDICT MRI, Diagnostic Test: Luminal Index Imaging |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Men aged 18-90 with a clinical suspicion of prostate cancer
- No contraindication to MRI
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERDICT MRIAdvanced Diffusion Model | Diagnostic test | Men suspected of Prostate Cancer |
| Luminal Index ImagingAdvanced T2 mapping | Diagnostic test | Men suspected of Prostate Cancer |
Primary outcome
Diagnostic accuracy of VERDICT MRI
Time frame: 2 years
Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone
Diagnostic accuracy of Luminal Water Imaging (LWI)
Time frame: 2 years
Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone
1 secondary outcome
The proportions of true positives with index tests is the same as mpMRI.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 35396316Singh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shonit Punwani principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Neoplasm, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joey Clemente (07886178028, j.clemente@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of VERDICT MRI (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.