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

NCT ID: NCT02940041

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• >18 years old
• Accept to participate in the study
• uterine leiomyomas who have >2 risk factors for mesenchymal uterine malignant tumor OR sonographic suspicion of atypical leiomyoma.

Exclusion Criteria

• < 18 years
• Not being capable of understanding the study design

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IIBSP-TUM-2016-30

Identifier Type: -

Identifier Source: org_study_id