Clinical trial NCT02940041: Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors
Official title: Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchymal Malignant Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Leiomyoma
Leiomyosarcoma
Keywords: Diagnosis
Sonography
Magnetic Resonance
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over 18 years old with uterine leiomyomas who have \>2 risk factors for mesenquimal uterine malignant tumor OR sonographic suspicion of atypical leiomyoma.

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.

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

Primary outcomes:
measure: Concordance Between Gynaecologic Sonography Amd Pelvic MRI
timeFrame: We expect to recruit 50 patients in 1 year period
Secondary outcomes:
measure: Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors
timeFrame: We expect to recruit 50 patients in 1 year period
Other outcomes:
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Study officials:
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