Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology — MUSA1  

Myoma;Uterus Clinical Trial

Official title: Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 (described in Addendum 1) will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). Figure 1 shows the different histological endpoint with expected prevalence in our study population and table 1 further differentiate those histological endpoints. The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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 ;

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Sarcoma Uterus

• NCT number: NCT04990076
• Study type: Observational
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Christine De Bruyn, MD
• Phone: +32 16 345125
• Email: christine.debruyn@uzleuven.be
• Status: Recruiting
• Start date: March 11, 2020
• Completion date: March 30, 2024