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

Last updated: July 1, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Fibroids

Desmoid Tumors

Uterina Myoma

Treatment

Hysterectomy

Clinical Study ID

NCT04990076
s62497
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma).

Exclusion

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

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: Hysterectomy
Phase:
Study Start date:
March 11, 2020
Estimated Completion Date:
March 30, 2026

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

Connect with a study center

  • UZ Leuven

    Leuven, 300
    Belgium

    Active - Recruiting

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