Additive Role of ADC Value to ORADS in Adnexal Lesions

NCT07202429CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Cairo University

Enrollment

66

Start Date

2023-03-01

Completion Date

2024-06-01

Study Type

OBSERVATIONAL

Official Title

Additive Role of Mean Apparent Diffusion Coefficient (ADCmean) Value Measurements to the Ovarian-Adnexal Reporting and Data System (O-RADS) MRI Score in Stratifications of Adnexal Lesions

Interventions

MRI

Conditions

Ovarian Neoplasms

Eligibility

Sex

FEMALE

Inclusion Criteria:

* (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 Criteria:

1. Female patient any age with adnexal lesions detected by U/S reported as O-RADS1and2.
2. Cysts that were deemed to be clearly physiological and less than 3 cm in maximum diameter.
3. No histopathological findings or follow-up \< one year .
4. Previous bilateral adnexectomy.
5. 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,……)

Outcome Measures

Primary Outcomes

Mean ADC value of adnexal lesions

Measurement of mean apparent diffusion coefficient (ADCmean) values in adnexal lesions using diffusion-weighted imaging (DWI). Unit of Measure: ADC value (×10-³ mm²/s)

Time frame: March 2023 to june 2024

Diagnostic performance of O-RADS MRI + ADC system

Evaluation of diagnostic performance (sensitivity, specificity, accuracy) of O-RADS MRI scoring combined with ADC values, compared with O-RADS MRI system alone. Unit of Measure: Percentage (%)

Time frame: March 2023 to june 2024

Locations

Kasr Al-Ainy Faculty of Medicine, Cairo University, Cairo, Egypt

Additive Role of ADC Value to ORADS in Adnexal Lesions