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

ConditionsMyoma;Uterus Sarcoma Uterus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patient's refusal

Age < 18 years

Polymyomatous uterus

Myometrial lesion with a diameter less then 10mm

Trial population

Patients planned for hysterectomy with a myometrial lesion

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Hysterectomy
Procedure/Surgery
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.

Treatment groups

1,500 Participants

are divided into 1 treatment group

Group A: Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

4 years

Secondary outcomes

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).

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov

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