Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Imperial College London
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Accuracy of predicting lymph node metastasis using 3D USS
Study Overview
Brief Summary
Aim: Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer.
This study will assess whether 3D ultrasound is accurate at predicting myometrial invasion aqnd lymph node metastasis of endometrial cancer. All patients will receive routine standard of care (MRI). The results of the 3D ultrasound will be compared to the MRI report and final histology.
Detailed Description
Aim:
Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer.
Background:
When a diagnosis of endometrial cancer is confirmed on biopsy, women get staged to assess the level of spread. Current gold standard is an MRI. A proportion of women, are unable to undergo or complete an MRI scan due to their morbid obesity or claustrophobia. To this end, many have assessed the role of ultrasound in staging endometrial cancer as a cheaper and easier alternative to an MRI. In the last 20 years there has been a rise in the use of 3D ultrasound as it has become commercially available. There is, however a paucity of data on the role of 3D ultrasound in the assessment of myometrial invasion and lymph node metastasis. This research project will assess whether 3D ultrasound is a safe, effective alternative to MRI to assess the depth of spread of womb cancer.
The study:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.
Exclusion Criteria
- •Anyone lacking capacity. <18years old. Pregnant.
Arms & Interventions
3D ultrasound and MRI
All patients with confirmed endometrial cancer will recieve the gold standard pre-operative imaging (MRI) but will also be offered 3D ultrasound.
Intervention: 3D Ultrasound (Diagnostic Test)
Outcomes
Primary Outcomes
Accuracy of predicting lymph node metastasis using 3D USS
Time Frame: 1.5 years
Measuring 3D volume of tumour and assess if correlation with lymph node metastasis
Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI
Time Frame: 1.5 years
Sensitivity, specificity, negative and positive predictive value in diagnosing myometrial invasion.
Secondary Outcomes
No secondary outcomes reported