A comparison of the accuracies of ultrasound and magnetic resonance imaging in assessing the spread of womb cancer
Not Applicable
Completed
- Conditions
- Preoperative diagnoses of deep myometrial invasion and cervical stromal invasion in women with endometrial cancerCancerMalignant neoplasm: Endometrium
- Registration Number
- ISRCTN24363390
- Lead Sponsor
- niversity College London Hospitals NHS Foundation Trust
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35128854/ (added 12/04/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 51
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> At a single time point:<br> The diagnostic accuracies of ultrasound and MRI for DMI and CSI in endometrial cancer<br> 1. Sensitivity measured using the findings from the respective imaging test with histology as the reference standard.<br> 2. Specificity measured using the findings from the respective imaging test with histology as the reference standard.<br> 3. Positive likelihood ratio measured using the findings from the respective imaging test with histology as the reference standard.<br> 4. Negative likelihood ratio measured using the findings from the respective imaging test with histology as the reference standard.<br> 5. Overall accuracy measured using the findings from the respective imaging test with histology as the reference standard.<br>
- Secondary Outcome Measures
Name Time Method <br> At a single time point:<br> 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.<br> 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).<br> 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.<br>