Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchimal Malignant Tumors (CERTUM)
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|ClinicalTrials.gov Identifier: NCT02940041|
Recruitment Status : Unknown
Verified October 2016 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was: Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
|Condition or disease||Intervention/treatment|
|Leiomyoma Leiomyosarcoma||Procedure: Pre-surgical diagnosis of uterine malignant tumors|
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 MUSA (Morphological Uterus Sonographic Assessment) and the pelvic MRI for the pre-surgical diagnosis of malignant mesenquimal 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 mesenchimal 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 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 phisicians.
Then patients included will be adressed 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-patological report of the surgery specimen. All data will be entered in the database for futher analysis.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchimal Malignant Tumors|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
- 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.
- Concordance Between Gynaecologic Sonography Amd Pelvic MRI [ Time Frame: We expect to recruit 50 patients in 1 year period ]
- Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors [ Time Frame: We expect to recruit 50 patients in 1 year period ]Sonographic parameters : Undefined margins, Unique or multiple lesions, Size and Color-score (1,2,3,4) MRI parameters: Heterogenic or intermediate T2 Signal intensity , High or Intermediate b1000 signal, Apparent diffusion parameter <1.23, heterogeneus contrast catchment