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

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.

Study Overview

• Status: Recruiting
• Conditions: Myoma;Uterus; Sarcoma Uterus
• Intervention / Treatment: Procedure: Hysterectomy

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Christine De Bruyn, MD; Phone Number: +32 16 345125; Email: christine.debruyn@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 300
    • Recruiting
    • UZ Leuven
    • Contact: Christine De Bruyn, MD; Phone Number: +32 16 345125; Email: christine.debruyn@uzleuven.be
    • Principal Investigator: Dirk Timmerman, MD, PhD
    • Sub-Investigator: Thierry Van den Bosch, MD, PhD
    • Sub-Investigator: Ben Van Calster, MD, PhD
    • Sub-Investigator: Christine De Bruyn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients planned for hysterectomy with a myometrial lesion

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dirk Timmerman, MD, PhD, UZ Leuven

Publications and helpful links

General Publications

• Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installe AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brolmann H, Goldstein S, Epstein E, Bourne T, Timmerman D. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound Obstet Gynecol. 2015 Sep;46(3):284-98. doi: 10.1002/uog.14806. Epub 2015 Aug 10.
• Ludovisi M, Moro F, Pasciuto T, Di Noi S, Giunchi S, Savelli L, Pascual MA, Sladkevicius P, Alcazar JL, Franchi D, Mancari R, Moruzzi MC, Jurkovic D, Chiappa V, Guerriero S, Exacoustos C, Epstein E, Fruhauf F, Fischerova D, Fruscio R, Ciccarone F, Zannoni GF, Scambia G, Valentin L, Testa AC. Imaging in gynecological disease (15): clinical and ultrasound characteristics of uterine sarcoma. Ultrasound Obstet Gynecol. 2019 Nov;54(5):676-687. doi: 10.1002/uog.20270. Epub 2019 Oct 7.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: s62497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No