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

Primary Purpose

Endometrial Cancer, Endometrial Neoplasms, Endometrial Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
3D Ultrasound
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring endometrial cancer, staging, 3 Dimensional, Ultrasound, Myometrial invasion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen Charlotte and Hammersmith HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3D ultrasound and MRI

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI
Sensitivity, specificity, negative and positive predictive value in diagnosing myometrial invasion.
Accuracy of predicting lymph node metastasis using 3D USS
Measuring 3D volume of tumour and assess if correlation with lymph node metastasis

Secondary Outcome Measures

Full Information

First Posted
June 30, 2017
Last Updated
February 11, 2021
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03207061
Brief Title
Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?
Official Title
Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: All women with suspected endometrial cancer will receive a pelvic (internal) ultrasound as per routine care. In addition to the normal 2D ultrasound, women will receive a 3D ultasound and images will be saved. This adds an additional 1-2 minutes scan time. In those women with confirmed cancer on histology an MRI is performed to assess stage of cancer (current routine standard of care). This will include T1, T2, DWI and contrast enhanced sequences. Patients referred to Hammersmith Hospital from other trusts will also be able to undergo a 3D ultrasound if this was not already performed. Definitive management of endometrial cancer includes a hysterectomy and the surgical specimen will be examined for depth of myometrial invasion and lymph node involved (if removed). In the meantime, the saved 3D ultrasound images will be analysed and rendered to predict the stage of the endometrial cancer and lymph node involvement. The results of 3D ultrasound, and MRI will be compared against the stage found on the gold standard test (on histological examination).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Endometrial Neoplasms, Endometrial Hyperplasia
Keywords
endometrial cancer, staging, 3 Dimensional, Ultrasound, Myometrial invasion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D ultrasound and MRI
Arm Type
Other
Arm Description
All patients with confirmed endometrial cancer will recieve the gold standard pre-operative imaging (MRI) but will also be offered 3D ultrasound.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D Ultrasound
Intervention Description
A 3D ultrasound will be performed for all patients presenting to the clinic for suspected endometrial cancer (in addition to routine standard of care)
Primary Outcome Measure Information:
Title
Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI
Description
Sensitivity, specificity, negative and positive predictive value in diagnosing myometrial invasion.
Time Frame
1.5 years
Title
Accuracy of predicting lymph node metastasis using 3D USS
Description
Measuring 3D volume of tumour and assess if correlation with lymph node metastasis
Time Frame
1.5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study looking at endometrial cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Marcus, MB BS
Phone
020 7589 5111
Email
d.marcus16@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Yazbek, FRCOG
Email
joseph.yazbek@nhs.net
Facility Information:
Facility Name
Queen Charlotte and Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Marcus, MB BS
Email
d.marcus16@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Joseph Yazbek, FRCOG PhD
First Name & Middle Initial & Last Name & Degree
Sadaf Ghaem-Maghami, FRCOG PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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