Evaluating ultrasound methods for diagnosing uterine lesions
Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.
Universitaire Ziekenhuizen KU Leuven · NCT04990076
This study is testing if a new way of using ultrasound can help doctors tell the difference between benign and malignant uterine lesions in patients who are having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04990076 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of the MUSA terminology in differentiating between various myometrial lesions greater than 1 cm, including benign and malignant conditions. Patients scheduled for hysterectomy due to myometrial pathology will undergo a systematic preoperative ultrasound scan, where around 50 ultrasound characteristics will be evaluated. The study also seeks to develop a predictive model to distinguish between benign and malignant lesions based on selected ultrasound features. The findings could enhance preoperative diagnostic capabilities for uterine conditions.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for hysterectomy due to myometrial lesions larger than 1 cm.
Not a fit: Patients with myometrial lesions smaller than 10 mm or those with other concurrent gynecological pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing myometrial lesions, leading to better treatment decisions for patients.
How similar studies have performed: While the approach is based on established terminology, the specific application of MUSA terms in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma). Exclusion Criteria: * Patient's refusal * Age \< 18 years * Polymyomatous uterus * Myometrial lesion with a diameter less then 10mm * Patients currently treated for another cancer * Patients with ovarian pathology, endometrial pathology of cervical pathology * Power morcellation
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Principal investigator: Dirk Timmerman, MD, PhD — UZ Leuven
- Study coordinator: Christine De Bruyn, MD
- Email: christine.debruyn@uzleuven.be
- Phone: +32 16 345125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myoma, Uterus, Sarcoma Uterus