Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology

Recruiting

• Conditions: Myoma;Uterus; Sarcoma Uterus
• Interventions: Procedure: Hysterectomy

• Registration Number: NCT04990076
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The main objective is to evaluate the diagnostic accuracy of the MUSA terms and definitions, as defined in the paper by Van den Bosch T, Dueholm M, ea. in 2015, to differentiate between different types of myometrial lesions of more than 1 cm. The primary aim is the diagnostic accuracy of the MUSA terms and definitions and the secondary aim the development of a prediction model.

Detailed Description

Primary aim: Diagnostic accuracy of the MUSA terms and definitions

Every patient planned for hysterectomy for myometrial pathology (e.g. benign fibroid, benign adenomyoma or malignant uterine sarcoma) will undergo a systematic preoperative ultrasound scan. Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an incidence of 4.9% for uterine sarcomas amongst women with a myometrial lesion referred to their tertiary center (Antonia Testa, personal communication).

Secondary aim: Development of prediction model

The Secondary aim is to build predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma). Because of the small number of cases with malignant myometrial lesion (expected to be 5% of the study population or around 75 women), we will limit the number of variables to be tested in order to avoid overfitting. Based on current literature, we preselected following characteristics for development of a prediction model:

* Outer contour: regular of irregular

* Echogenicity of uterine lesion: uniform (homogeneous) or non-uniform (mixed)

* Colour score: 1 to 4

* Presence of central necrosis

* Maximal diameter of the lesion (in mm)

* Presence of acoustic shadows

Study Timeline

• Study Start: 2020-03-11
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.	Hysterectomy	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the MUSA terms and definitions	4 years	Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions).

Secondary Outcome Measures

Name	Time	Method
Development of prediction model	5 years	predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma).

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium