NCT04990076

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

Conditions

• Myoma;Uterus
• Sarcoma Uterus

Interventions

Type	Name	Description
PROCEDURE	Hysterectomy	Surgery includes different types of hysterectomy: vaginal hysterectomy, total abdominal hysterectomy and laparoscopic or Robotic hysterectomy. The type of hysterectomy does not influence histological outcome, as long as the uterus is removed in one part (no power morcellation). Indications for surgery and the type of surgery are according to the departments' protocols. If the patient is deemed to be inoperable due to the extent of the disease, a representive biopsy (e.g. trucut biopsy) will be accepted if sufficiently motivated by the oncology team.

Timeline

• Start date: 2020-03-11
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2021-08-04
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium