A comparison of the accuracies of ultrasound and magnetic resonance imaging in assessing the spread of womb cancer
| ISRCTN | ISRCTN24363390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24363390 |
| Secondary identifying numbers | 10/0316 |
- Submission date
- 28/03/2021
- Registration date
- 06/08/2021
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The spread of womb cancer is commonly estimated by an MRI scan before surgery, however, some studies reported that ultrasound could be as accurate as MRI. The potential benefits of ultrasound are its wider availability, lower cost and fewer contraindications compared to MRI. The aim of this study is to compare the accuracy of ultrasound and MRI in assessing the spread of womb cancer before surgery.
Who can participate?
All women with postmenopausal bleeding who are suspected of womb cancer on ultrasound in our clinic.
What does the study involve?
In women who are already undergoing transvaginal ultrasound assessment for postmenopausal bleeding, it involves having a simultaneous ultrasound assessment for the spread of womb cancer. All women with a confirmed diagnosis of womb cancer on biopsy will also be invited for an MRI scan to assess the spread of cancer.
What are the possible benefits and risks of participating?
The potential benefit is that women will have both tests to assess the spread of their womb cancer.
The potential risks are discomfort and inconvenience of having both tests, as well as, the risks of false-positive and false-negative diagnoses on ultrasound and MRI.
Where is the study run from?
Gynaecology Diagnostic and Treatment Unit, University College London Hospitals, London, UK
When is the study starting and how long is it expected to run for?
May 2011 to October 2018
Who is funding the study?
University College London Hospitals (UK)
Who is the main contact?
Dr Michael Wong, michael.wong3@nhs.net
Contact information
Scientific
Gynaecology Diagnostic and Treatment Unit
235 Euston Road
London
NW1 2BU
United Kingdom
 ORCID ID |
0000-0002-2168-1111 |
|---|---|
| Phone | +44 (0)20 3456 7890 |
| michael.wong3@nhs.net |
Public
Gynaecology Diagnostic and Treatment Unit
235 Euston Road
London
NW1 2BU
United Kingdom
| Phone | +44 (0)20 3456 7890 |
|---|---|
| michael.wong3@nhs.net |
Study information
| Study design | Single centre cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A prospective comparison of the diagnostic accuracies of ultrasound and magnetic resonance imaging in preoperative staging of endometrial cancer |
| Study objectives | The diagnostic accuracy of ultrasound is comparable to MRI for the prediction of deep myometrial invasion and cervical stromal invasion in women with endometrial cancer. |
| Ethics approval(s) | Approved 31/05/2011, Central London REC2 committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; londoncentral.rec@hra.nhs.uk), ref: 10/H0713/66 |
| Health condition(s) or problem(s) studied | Preoperative diagnoses of deep myometrial invasion and cervical stromal invasion in women with endometrial cancer |
| Intervention | Consecutive women presenting with postmenopausal bleeding to our gynaecology outpatient clinic during the study period are potentially eligible. Women who have previously undergone a hysterectomy or already diagnosed with gynaecological malignancy will be excluded. All women will be assessed by a single clinical research fellow, who has undergone intensive training in early pregnancy and gynaecological ultrasound prior to the start of the study. He will assess for the presence of endometrial cancer based on ultrasound subjective pattern recognition. All women will be divided into the following groups: 1. suspected endometrial cancer, 2. benign endometrial polyps, 3. uniformly thickened endometrium, 4. atrophic endometrium, 5. unsatisfactory ultrasound assessment. All women with an unsatisfactory transvaginal ultrasound assessment or an axial uterus will be offered a transrectal ultrasound scan, saline infusion sonography or outpatient/day-case hysteroscopy. Women with suspected endometrial cancer will simultaneously undergo a subjective assessment for the depth of myometrial invasion (1. no myometrial invasion or <50% myometrial invasion of the entire myometrial thickness, 2. ≥50% myometrial thickness) and cervical stromal invasion (present or absent). An outpatient endometrial biopsy (pipelle) will then be taken after the ultrasound scan. Hysteroscopy will be offered to those who decline or failed with an outpatient endometrial biopsy. All women with a histologically confirmed diagnosis of endometrial cancer will be advised to undergo a preoperative MRI to assess for the depth of myometrial invasion and cervical stromal invasion by an experienced consultant radiologist in gynaecological oncology. The radiologist involved will be blinded to the ultrasound findings and the presence or absence of DMI and CSI will be assessed subjectively. The standard MRI protocol will involves T2-weighted imaging (T2WI), dynamic T1-weighted gadolinium sequences (DCE-MRI) and diffusion-weighted imaging (DWI-MRI) with an apparent diffusion coefficient map. Women with endometrial cancer will be managed by a consultant gynaecological oncologist who will not take part in the study and each woman's management will be discussed routinely at a multi-disciplinary team meeting. The diagnostic accuracies of ultrasound and MRI for deep (≥50%) myometrial invasion and cervical stromal invasion will be compared with the final histology (hysterectomy) as the gold standard. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | At a single time point: The diagnostic accuracies of ultrasound and MRI for DMI and CSI in endometrial cancer 1. Sensitivity measured using the findings from the respective imaging test with histology as the reference standard. 2. Specificity measured using the findings from the respective imaging test with histology as the reference standard. 3. Positive likelihood ratio measured using the findings from the respective imaging test with histology as the reference standard. 4. Negative likelihood ratio measured using the findings from the respective imaging test with histology as the reference standard. 5. Overall accuracy measured using the findings from the respective imaging test with histology as the reference standard. |
| Secondary outcome measures | At a single time point: 1. The accuracy of ultrasound subjective pattern recognition in diagnosing endometrial cancer (sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and overall accuracy) measured using the findings on ultrasound scan with histology as the reference standard. 2. The number of unsatisfactory ultrasound assessments to diagnose and stage endometrial cancer amongst women with postmenopausal bleeding (as a proportion of the total number of women included in the study). 3. The efficacies of transrectal ultrasound scan and saline infusion sonography (as a proportion of the total number of unsatisfactory ultrasound assessments) measured using patient records. |
| Overall study start date | 31/05/2011 |
| Completion date | 02/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 49 |
| Total final enrolment | 51 |
| Key inclusion criteria | 1. Postmenopausal women (at least 45 years of age with at least 1 year of amenorrhea) 2. Presenting with postmenopausal bleeding, including women with unscheduled bleeding whilst on hormone replacement therapy |
| Key exclusion criteria | 1. Women with a previous history of hysterectomy 2. Women with a known diagnosis of gynaecological malignancy 3. Women who decline a transvaginal or transrectal ultrasound scan 4. Women who have a contraindication to MRI scan 5. Women who are managed expectantly (without hysterectomy) following a diagnosis of endometrial cancer |
| Date of first enrolment | 07/10/2015 |
| Date of final enrolment | 02/10/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
235 Euston Road
London
NW1 2BU
United Kingdom
Sponsor information
Hospital/treatment centre
235 Euston Road
London
NW1 2BU
England
United Kingdom
| Phone | +44 (0)20 3456 7890 |
|---|---|
| uclh.randd@nhs.net | |
| Website | https://www.uclh.nhs.uk/Pages/home.aspx |
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University College London Hospitals, UCLH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2022 | 12/04/2022 | Yes | No |
Editorial Notes
12/04/2022: Publication reference added.
06/08/2021: Trial's existence confirmed by UCL
