Clinical trial · Observational
Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology
Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.
NCT04990076CI-TRIAL-00078468MUSA1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myoma;Uterus | — | UNRESOLVED | — |
| Sarcoma Uterus | Myofibroma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.
- interventionNames
- Procedure: Hysterectomy
Primary outcomes (1)
- measure
- Diagnostic accuracy of the MUSA terms and definitions
- timeFrame
- 4 years
- description
- Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions).
Secondary outcomes (1)
- measure
- Development of prediction model
- timeFrame
- 5 years
- description
- predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVan 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. PMID 25652685
- BACKGROUNDLudovisi 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. PMID 30908820