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

NCT03207061 | Unknown

• 1 other identifier: 16HH3687 3D Ultrasound EC
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Endometrial Neoplasms; Endometrial Hyperplasia

Keywords

endometrial cancer; staging; 3 Dimensional; Ultrasound; Myometrial invasion

Outcome Measures

Primary Outcomes (2)

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

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

  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

  1.5 years

Study Arms (1)

3D ultrasound and MRI

OTHER

All patients with confirmed endometrial cancer will recieve the gold standard pre-operative imaging (MRI) but will also be offered 3D ultrasound.

Diagnostic Test: 3D Ultrasound

Interventions

3D Ultrasound DIAGNOSTIC_TEST

A 3D ultrasound will be performed for all patients presenting to the clinic for suspected endometrial cancer (in addition to routine standard of care)

3D ultrasound and MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study looking at endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.

You may not qualify if:

• Anyone lacking capacity. \<18years old. Pregnant.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Queen Charlotte and Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Diana Marcus, MB BS

CONTACT

020 7589 5111; d.marcus16@imperial.ac.uk

Joseph Yazbek, FRCOG

CONTACT

joseph.yazbek@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: June 13, 2017
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

GB (1)