Endometrial CancerNCT03207061
Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?
A study testing 3D Ultrasound in people with Endometrial Cancer and Endometrial Neoplasms, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Neoplasms, Endometrial Hyperplasia
- What is being tested?
- 3D Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2017to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.
Who cannot join
- Anyone lacking capacity. <18years old. Pregnant.
Trial locations and contacts
1 site in 1 country.
Joseph Yazbek, FRCOG contact
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Charlotte and Hammersmith Hospital
London, W12 0HS
Diana Marcus, MB BS, d.marcus16@imperial.ac.uk
Joseph Yazbek, FRCOG PhD
About this study
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.
Read the 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).
- Being tested
- 3D Ultrasound
- Keywords
- endometrial cancer, staging, 3 Dimensional, Ultrasound, Myometrial invasion
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D UltrasoundDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 3D Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI
Sensitivity, specificity, negative and positive predictive value in diagnosing myometrial invasion.
Measured: 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
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start13 Jun 2017
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207061
- Sponsor's protocol ID
- 16HH3687 3D Ultrasound EC
- Status last verified
- Feb 2021
- First submitted
- 30 Jun 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?
- ClinicalTrials.gov ID
- NCT03207061
- Acronym / sponsor ID
- 16HH3687 3D Ultrasound EC
- Keywords
- endometrial cancer, staging, 3 Dimensional, Ultrasound, Myometrial invasion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D ultrasound and MRI | Other | Diagnostic Test: 3D UltrasoundAll patients with confirmed endometrial cancer will recieve the gold standard pre-operative imaging (MRI) but will also be offered 3D ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.
Key exclusion criteria (1 listed)
- Anyone lacking capacity. <18years old. Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D UltrasoundA 3D ultrasound will be performed for all patients presenting to the clinic for suspected endometrial cancer (in addition to routine standard of care) | Diagnostic test | 3D ultrasound and MRI |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Yazbek, FRCOG contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Ultrasound in people with Endometrial Cancer and Endometrial Neoplasms, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Marcus, MB BS (020 7589 5111, d.marcus16@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of diagnosing myometrial invasion in 3D USS compared to MRI (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.