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

Leiomyoma Clinical Trial

— CERTUM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02940041
• Other study ID #: IIBSP-TUM-2016-30
• Status: Terminated
• Start date: September 2016
• Est. completion date: September 2021

Study information

• Verified date: November 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2021
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyosarcoma
• Neoplasms
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance Between Gynaecologic Sonography Amd Pelvic MRI		We expect to recruit 50 patients in 1 year period
Secondary	Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors	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, heterogeneous contrast catchment	We expect to recruit 50 patients in 1 year period