Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?

NCT ID: NCT03543215

Last Updated: 2021-02-12

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

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-13

Study Completion Date

2025-12-10

Brief Summary

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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

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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

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Endometrial Cancer Endometrial Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Anyone lacking capacity.
* \<18years old.
* Pregnant.
* No MR Imaging available for review -- No pathology specimen available for review
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Charlotte and Hammersmith Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Diana Marcus, MB BS

Role: CONTACT

020 7589 5111

Facility Contacts

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Diana Marcus, MB BS

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38724889 (View on PubMed)

Other Identifiers

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16HH3687 Radiomics EC

Identifier Type: -

Identifier Source: org_study_id

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