Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02940041
Other study ID # IIBSP-TUM-2016-30
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT00160381 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Recruiting NCT04214457 - Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
Completed NCT00044876 - Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist Phase 2
Completed NCT02889848 - Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids) Phase 1
Recruiting NCT04145518 - Mechanistic Characterization of Uterine Pain Phase 4
Completed NCT01816815 - Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670 Phase 1
Completed NCT00891657 - Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy N/A
Completed NCT00156156 - Study of Asoprisnil in the Treatment of Uterine Fibroids. Phase 3
Recruiting NCT05538689 - Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL) Phase 4
Active, not recruiting NCT03323905 - Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas N/A
Terminated NCT03342859 - Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned Phase 1
Recruiting NCT06135870 - Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
Completed NCT02777203 - Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT02189083 - Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids Phase 3
Completed NCT01123603 - Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata N/A
Completed NCT00160459 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 2