Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?

NCT03207061UNKNOWNNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Imperial College London

Enrollment

500

Start Date

2017-06-13

Completion Date

2021-12-01

Study Type

INTERVENTIONAL

Official Title

Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?

Interventions

3D Ultrasound

Conditions

Endometrial CancerEndometrial NeoplasmsEndometrial Hyperplasia

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI

Sensitivity, specificity, negative and positive predictive value in diagnosing myometrial invasion.

Time frame: 1.5 years

Accuracy of predicting lymph node metastasis using 3D USS

Measuring 3D volume of tumour and assess if correlation with lymph node metastasis

Time frame: 1.5 years

Locations

Queen Charlotte and Hammersmith Hospital, London, United Kingdom

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.