Status:

COMPLETED

Additive Role of ADC Value to ORADS in Adnexal Lesions

Lead Sponsor:

Cairo University

Conditions:

Ovarian Neoplasms

Eligibility:

FEMALE

Brief Summary

Evaluation of the impact of adding mean apparent diffusion coefficient (ADC mean) measurements to the Ovarian-Adnexal Imaging Reporting and Data System MRI (O-RADS MRI) scoring for adnexal lesion char...

Detailed Description

The patients will be referred from the Gynecology department to the Kasr Al-Ainy Radiology department (Women's imaging unit) based on preliminary ultrasound examination used for cases selection. Fema...

Eligibility Criteria

Inclusion

  • (1) Female patient any age with at least one adnexal lesion detected by U/S reported as O-RADS3to5.
  • (2) The interval between operation and ultrasonography did not exceed 120 days. (3) Subsequent surgery with histological examination or stability at follow-up imaging for at least 1 year.
  • (4) For bilateral adnexal masses, the mass with the most complex features was included.
  • (5)If two masses had similar morphologies, the largest mass was included.

Exclusion

  • Female patient any age with adnexal lesions detected by U/S reported as O-RADS1and2.
  • Cysts that were deemed to be clearly physiological and less than 3 cm in maximum diameter.
  • No histopathological findings or follow-up \< one year .
  • Previous bilateral adnexectomy.
  • Contraindications to MRI examination including
  • Absolute contraindications: such as The cardiac implantable electronic device (CIED), Metallic intraocular foreign bodies, ….)
  • Relative contraindications: such as Coronary and peripheral artery stents, Ocular prosthesis,……)

Key Trial Info

Start Date :

March 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2025

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT07202429

Start Date

March 1 2023

End Date

January 1 2025

Last Update

October 1 2025

Active Locations (1)

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1

Kasr Al-Ainy Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt, 11562