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?
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).
Study Type
Interventional
Primary Outcome
Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI
Condition
Endometrial Cancer
Intervention
3D Ultrasound
Study Arms / Comparison Groups
3D ultrasound and MRI
Description: All patients with confirmed endometrial cancer will recieve the gold standard pre-operative imaging (MRI) but will also be offered 3D ultrasound.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
500
Start Date
June 13, 2017
Completion Date
January 1, 2022
Primary Completion Date
December 1, 2021
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 020 7589 5111, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03207061
Organization ID
16HH3687 3D Ultrasound EC
Responsible Party
Sponsor
Study Sponsor
Imperial College London
Study Sponsor
, ,
Verification Date
February 2021