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NCT Number: NCT04990076

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

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.

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Key information

Conditions

Myoma;Uterus Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma Uterus Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UZ Leuven

Leuven, 300, Belgium

Location status: Recruiting

Location contact

Ben Van Calster, MD, PhD

SUB_INVESTIGATOR

Christine De Bruyn, MD

CONTACT

[email protected]

+32 16 345125

Christine De Bruyn, MD

SUB_INVESTIGATOR

Dirk Timmerman, MD, PhD

PRINCIPAL_INVESTIGATOR

Thierry Van den Bosch, MD, PhD

SUB_INVESTIGATOR

About this study

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysterectomy

Procedure

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.

Primary outcomes

  1. Diagnostic accuracy of the MUSA terms and definitions

    Time frame: 4 years

    Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions).

Secondary outcomes

  1. Development of prediction model

    Time frame: 5 years

    predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma).

Study contacts

Contact information is provided by the study sponsor or research team.

Christine De Bruyn, MD

CONTACT

[email protected]

+32 16 345125

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: MUSA1

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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