NCT02940041

Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors

Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchymal Malignant Tumors

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine the concordance between gynaecological sonography and pelvic MRI for the pre-surgical diagnosis of uterine malignant tumors.

Detailed description

The hypothesis that will be evaluated with this study is the concordance between the sonographic assessment following the terms and definitions to describe uterine pathology proposed by Morphological Uterus Sonographic Assessment (MUSA) and the pelvic MRI for the pre-surgical diagnosis of malignant mesenchymal uterine tumors in patients affected of symptomatic leiomyomas with clinical or sonographic risk factors for atypical fibroids. If both explorations have the same efficiency for the diagnosis, one of those should be avoided, diminishing the costs and surgery delay for these patients. Those women with uterine leiomyoma who present \>2 risk factors for uterine malignant mesenchymal tumors OR with sonographic criteria for atypical leiomyoma will be invited to participate in the study and will sign the informed consent. After this first visit, the patient will undergo a gynecological sonography, serum lactate dehydrogenase (LDH) determination and a pelvic MRI, as it is done in our regular clinical practice. All explorations will be performed in the same study center and will be done by independent physicians. Then patients included will be addressed to a second visit to explain the results and surgery planning if it's needed. One month after the surgery, one last visit will be conducted to perform a post-surgery control and give the final anatomo-pathological report of the surgery specimen. All data will be entered in the database for further analysis.

Conditions

• Leiomyoma
• Leiomyosarcoma

Interventions

Type	Name	Description
PROCEDURE	Pre-surgical diagnosis of uterine malignant tumors	All patientes who fit inclusion criteria will undergo a gynecologic sonography, pelvic MRI, determination of LDH, as in regular practice. No additional interventions will be done to any patient.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2021-09-01
• First posted: 2016-10-20
• Last updated: 2023-12-26