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NCT06109545 Clinical Trial

Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

Ovarian Cancer Clinical Trial

Official title:
Validation of Doppler Ultrasound, CT Parameters Versus Laparoscopic Scoring in Assessment of Suspicious Ovarian Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06109545
Other study ID # SM.MD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2023
Est. completion date June 1, 2025

Study information
Verified date October 2023
Source Mansoura University
Contact Sarah Madany, MSc
Phone +201027991297
Email sarahmadany20@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Description:

The aim of this study is to asses validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Recruitment information / eligibility
Status Recruiting
Enrollment 95
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. all patients with clinical or radiological suspicion of ovarian cancer. 2. at least one of clinical presentation of suspected or advanced ovarian cancer and performed ultrasound or CT or MRI that detect a pelvic mass and CA125 is more than 200 UL/ML. 3. patients with eastern Cooperative Oncology Group status from 0 to 3. Exclusion Criteria: 1. the women outside the age group in our study. 2. any known malignancy at other sites. 3. uncompliant patients who have severed uncontrolled infection or any other medical problem. 4. any previous major surgery. 5. patients who refuse to give an informed consent to do laparoscopy. 6. pregnancy and its complications.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopy
Patients included in this study will have diagnostic laparoscopy type WOLF done after checking all above ultrasound parameters of malignant tumor. This procedure will be done under general anathesia then a verses needle will be used at umbilicus or at palmer point if the mass is large or in cases of umbilical hernia or previous abdominal or pelvic surgery, then Fagotti criteria will be assessed

Locations
Country Name City State
Egypt Mansoura University Hospital Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fagotti score Laparoscopic staging of suspicious ovarian mass Al time of laparoscopy
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