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

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ClinicalTrials.gov Identifier: NCT03543215
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Endometrial Cancer Endometrial Neoplasms Other: Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)

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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : December 10, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Assess the correlation between imaging features and histopathological features. [ Time Frame: 3 years ]
    Assess textural features of pelvic MRI in conjunction with histopathology (type of tumour, grade LVSI, 'aggressiveness' of cancer


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study is on endometrial cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients reviewed at the Specialist Gynaecology Oncology MDT at ICHNT with a diagnosis of endometrial cancer
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543215


Contacts
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Contact: Diana Marcus, MB BS 020 7589 5111 d.marcus16@imperial.ac.uk

Locations
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United Kingdom
Queen Charlotte and Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Diana Marcus, MB BS       d.marcus16@imperial.ac.uk   
Principal Investigator: Sadaf Ghaem-Maghami         
Principal Investigator: Andrea Rockall         
Principal Investigator: Nishat Bharwani         
Sponsors and Collaborators
Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03543215    
Other Study ID Numbers: 16HH3687 Radiomics EC
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
MRI
Radiomics
Texture features
Prognostication
Endometrial cancer
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases