Endometrial CancerNCT03543215
Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?
An observational study of Endometrial Cancer and Endometrial Neoplasms, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Neoplasms
- What is being tested?
- Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jul 2017to 10 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients reviewed at the Specialist Gynaecology Oncology MDT at ICHNT with a diagnosis of endometrial cancer
Who may be able to join
- All women presenting with a confirmed diagnosis of endometrial cancer
- Reviewed at the Specialist Gynaecology Oncology MDT
- Have MR Imaging and Hysterectomy specimens available for review.
Who cannot join
- Anyone lacking capacity.
- <18years old.
- Pregnant.
- No MR Imaging available for review -- No pathology specimen available for review
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Charlotte and Hammersmith Hospital
London, W12 0HS
Diana Marcus, MB BS, d.marcus16@imperial.ac.uk
Sadaf Ghaem-Maghami
About this study
Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer
This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.
Read the detailed description
Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer
Background:
Endometrial cancer is the commonest gynaecological cancer in the United Kingdom. MR Imaging is used to provide pre-treatment local staging in Endometrial Cancer based on the FIGO staging system. This MRI stage is used by clinicians, in combination with pre-operative histology and clinical assessment of the patient, to counsel patients about their prognosis.
Currently the information obtained from the MRI study is largely anatomical and concerns the extent of local tumour spread at the time of diagnosis. Each stage under the FIGO system is associated with a prognosis based on data from the literature. Important prognostic indicators include the depth of tumour invasion in the uterine muscle (myometrium), invasion of the cervical stroma by tumour, spread to lymph node tissues and the histological sub-type of tumour present.
However, with ever improving MRI technology there are now newer sequences employed as part of the staging study which may potentially yield more information. In other cancer types, e.g. prostate, breast and liver, textural analysis of the tumour on pre-treatment imaging (CT/PET-CT/MRI) is being analysed to try and identify features which could be used as prognostic markers for patient outcome.
The Study:
All patients with confirmed cancer on histology will receive an Ultrasound and MRI as part of routine care. The MRI scan will include T1, T2, DWI and contrast enhanced sequences. Patients referred to Hammersmith Hospital from other trusts who are diagnosed with endometrial cancer will be approached for consent and enrolment into latter part of study. These patients will have had an MRI but may not have had all the sequences needed and may therefore require a further MRI scan with additional sequences. These images will be saved and analysed. Pathological findings (e.g. type and grade of cancer) will be correlated with the radiological results.
Definitive management of endometrial cancer includes a hysterectomy for most patients. Following surgery patients will continue with routine standard of care and follow up. Patients will be followed up for 5 years to provide 5 year survival data. Images from ultrasound and MRI pelvis will be analysed to see if they can predict the 5 year survival.
This prospective study will also be used to validate a retrospective model using MRI textural features in endometrial cancer patients.
- Conditions
- Endometrial Cancer, Endometrial Neoplasms
- Being tested
- Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)
- Keywords
- MRI, Radiomics, Texture features, Prognostication, Endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)Other
All patients with confirmed endometrial cancer will have received Ultrasound and MRI as part of routine standard of care. Textural features from this will be analysed to see if can predict prognosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points
Assess features of pelvic MRIs (including (i) tumour image intensity, (II) shape, (III) texture and (IV) multiscale wavelet) and create a mathematical algorithm to predict prognostic outcome (5 year survival).
Measured: 8 years (3 year data collection and 5 year follow up).
Secondary outcomes (1)
Assess the correlation between imaging features and histopathological features.
Assess textural features of pelvic MRI in conjunction with histopathology (type of tumour, grade LVSI, 'aggressiveness' of cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start13 Jul 2017
- Primary completion10 Dec 2021 (estimated)
- Study completion10 Dec 2025 (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 Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Imperial 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543215
- Sponsor's protocol ID
- 16HH3687 Radiomics EC
- Status last verified
- Feb 2021
- First submitted
- 30 Jun 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Marcus D, Russell J, Aboagye EO, Ellis LB, Sheeka A, Park WE, Bharwani N, Ghaem-Maghami S, Rockall AG. Weibull parametric model for survival analysis in women with endometrial cancer using clinical and T2-weighted MRI radiomic features. BMC Med Res Methodol. 2024 May 9;24(1):107. doi: 10.1186/s12874-024-02234-1.
PubMed 38724889
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?
- ClinicalTrials.gov ID
- NCT03543215
- Acronym / sponsor ID
- 16HH3687 Radiomics EC
- Conditions
- Endometrial Cancer, Endometrial Neoplasms
- Keywords
- MRI, Radiomics, Texture features, Prognostication, Endometrial cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 1 Jun 2018 (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.
Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer
This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.
Detailed description
Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer
Background:
Endometrial cancer is the commonest gynaecological cancer in the United Kingdom. MR Imaging is used to provide pre-treatment local staging in Endometrial Cancer based on the FIGO staging system. This MRI stage is used by clinicians, in combination with pre-operative histology and clinical assessment of the patient, to counsel patients about their prognosis.
Currently the information obtained from the MRI study is largely anatomical and concerns the extent of local tumour spread at the time of diagnosis. Each stage under the FIGO system is associated with a prognosis based on data from the literature. Important prognostic indicators include the depth of tumour invasion in the uterine muscle (myometrium), invasion of the cervical stroma by tumour, spread to lymph node tissues and the histological sub-type of tumour present.
However, with ever improving MRI technology there are now newer sequences employed as part of the staging study which may potentially yield more information. In other cancer types, e.g. prostate, breast and liver, textural analysis of the tumour on pre-treatment imaging (CT/PET-CT/MRI) is being analysed to try and identify features which could be used as prognostic markers for patient outcome.
The Study:
All patients with confirmed cancer on histology will receive an Ultrasound and MRI as part of routine care. The MRI scan will include T1, T2, DWI and contrast enhanced sequences. Patients referred to Hammersmith Hospital from other trusts who are diagnosed with endometrial cancer will be approached for consent and enrolment into latter part of study. These patients will have had an MRI but may not have had all the sequences needed and may therefore require a further MRI scan with additional sequences. These images will be saved and analysed. Pathological findings (e.g. type and grade of cancer) will be correlated with the radiological results.
Definitive management of endometrial cancer includes a hysterectomy for most patients. Following surgery patients will continue with routine standard of care and follow up. Patients will be followed up for 5 years to provide 5 year survival data. Images from ultrasound and MRI pelvis will be analysed to see if they can predict the 5 year survival.
This prospective study will also be used to validate a retrospective model using MRI textural features in endometrial cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients reviewed at the Specialist Gynaecology Oncology MDT at ICHNT with a diagnosis of endometrial cancer
Key inclusion criteria (3 listed)
- All women presenting with a confirmed diagnosis of endometrial cancer
- Reviewed at the Specialist Gynaecology Oncology MDT
- Have MR Imaging and Hysterectomy specimens available for review.
Key exclusion criteria (4 listed)
- Anyone lacking capacity.
- <18years old.
- Pregnant.
- No MR Imaging available for review -- No pathology specimen available for review
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 |
|---|---|---|
| Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)All patients with confirmed endometrial cancer will have received Ultrasound and MRI as part of routine standard of care. Textural features from this will be analysed to see if can predict prognosis. | Other | – |
Primary outcome
To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points
Time frame: 8 years (3 year data collection and 5 year follow up).
Assess features of pelvic MRIs (including (i) tumour image intensity, (II) shape, (III) texture and (IV) multiscale wavelet) and create a mathematical algorithm to predict prognostic outcome (5 year survival).
1 secondary outcome
Assess the correlation between imaging features and histopathological features.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 38724889Li X, Marcus D, Russell J, Aboagye EO, Ellis LB, Sheeka A, Park WE, Bharwani N, Ghaem-Maghami S, Rockall AG. Weibull parametric model for survival analysis in women with endometrial cancer using clinical and T2-weighted MRI radiomic features. BMC Med Res Methodol. 2024 May 9;24(1):107. doi: 10.1186/s12874-024-02234-1.
- Individual participant dataSharing planned: No
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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.
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 Endometrial Cancer and Endometrial Neoplasms, run by Imperial 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 3 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 12 Feb 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 Diana Marcus, MB BS (020 7589 5111, d.marcus16@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points (time frame: 8 years (3 year data collection and 5 year follow up).). 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 NCT03543215, 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 12 Feb 2021.