CERTUM: Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchimal Malignant Tumors
Study Details
Study Description
Brief Summary
Determine the concordance between gynaecological sonography and pelvic MRI for the pre-surgical diagnosis of uterine malignant tumors.
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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 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 Design
Outcome Measures
Primary Outcome Measures
- Concordance Between Gynaecologic Sonography Amd Pelvic MRI [We expect to recruit 50 patients in 1 year period]
Secondary Outcome Measures
- Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years old
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Accept to participate in the study
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uterine leiomyomas who have >2 risk factors for mesenquimal uterine malignant tumor OR sonographic suspicion of atypical leiomyoma.
Exclusion Criteria:
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< 18 years
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Not being capable of understanding the study design
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIBSP-TUM-2016-30