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

Myoma;Uterus Clinical Trial

— MUSA1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990076
• Other study ID #: s62497
• Status: Recruiting
• Start date: March 11, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: July 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Christine De Bruyn, MD
• Phone: +32 16 345125
• Email: christine.debruyn[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

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.

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Sarcoma Uterus

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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, Frühauf 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. — View Citation

Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installé AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brölmann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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