(GI-RADS) in Preoperative Evaluation of Adnexal Masses

• ClinicalTrials.gov Identifier: NCT06403072
• Recruitment Status: Completed
• First Posted: May 7, 2024
• Last Update Posted: May 7, 2024
• Sponsor: Beni-Suef University
• Information provided by (Responsible Party): Sara Abdallah Mohamed Salem, Beni-Suef University

Tracking Information

• First Submitted Date: May 3, 2024
• First Posted Date: May 7, 2024
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: June 1, 2021
• Actual Primary Completion Date: January 4, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2024)

The Gynecologic Imaging-Reporting and Data System (GI-RADS) [ Time Frame: 1 month from admission to ultrasound investigation and operation and finally histopathology report ]

is a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: (GI-RADS) in Preoperative Evaluation of Adnexal Masses
• Official Title: Diagnostic Performance of the Gynecologic Imaging-Reporting and Data System (GI-RADS) in Preoperative Evaluation of Adnexal Masses
• Brief Summary: prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

Detailed Description

After institutional ethical committee approval () and informed consent from the patients, this prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

All women were subjected to the following:

1. Detailed history taking: Personal history, Age, Obstetric history, past history and family history.
2. Physical examination: General examination, Pelvic examination and Abdominal examination.
3. Investigations: Routine labs; CBC, liver and kidney functions, FBS and 2HPP. Other labs; cancer antigen 125 (CA 125) as a tumor marker.
4. Trans vaginal ultrasound: TVUS Written informed consent for participation and publication was obtained from each patient after receiving information about the details of the study. Confidentiality of patient's records was assured and maintained throughout the study.

One hundred (100) patients' pelvises were examined by transvaginal ultrasound in lithotomy position using endo-vaginal transducer and/or transabdominal ultrasound in the supine position in transverse and longitudinal plane and evaluated by B-mode ultrasonography, color, and spectral Doppler. Two expert examiners with more than 10 years' experience in gynecological ultrasound, performed all examinations and data was stored between one and four representative images on the database.

After the examinations, a combination of morphological features, color and spectral Doppler features, and then the lesion was evaluated according to GI-RADS classification, and the suggested management protocol based on the risk of malignancy.

Finally, the referral to surgery and decision-making were consulted in accordance with a multidisciplinary team meeting (MDT). A definitive histopathological diagnosis was obtained as a gold standard test for all patients with GI-RADS 4 and 5 and some cases of GI-RADS 3 patients after laparoscopic or surgical removal of the masses.

A morphologic evaluation was performed according to the International Ovarian Tumor Analysis Group (IOTA) recommendations for the following parameters: wall thickness, septation, papillary projections, presence and echogenicity of solid areas, presence of mixed component, cystic component, and presence of ascites and intra-abdominal metastases (peritoneal deposits, liver metastasis, and malignant abdominal lymphadenopathy) was also recorded. Pattern recognition analysis was also used for ovarian masses.

Statistical analysis:

The collected data was coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013 and Microsoft Office Excel 2007.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: women with pelvic pain due to accidently discovered adnexal mass
• Condition: Ovarian Cancer

Intervention

Diagnostic Test: The Gynecologic Imaging-Reporting and Data System (GI-RADS)

The Gynecologic Imaging-Reporting and Data System (GI-RADS) using ultrasound

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2024): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 30, 2023
• Actual Primary Completion Date: January 4, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Females complaining of pelvic pain due to adnexal mass

Exclusion Criteria:

• Presence of Sure signs of malignancy

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT06403072
• Other Study ID Numbers: GI-RADS
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Sara Abdallah Mohamed Salem, Beni-Suef University
• Original Responsible Party: Same as current
• Current Study Sponsor: Beni-Suef University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sara S Sara Salem; Beni-Suef University

• PRS Account: Beni-Suef University
• Verification Date: May 2024