Additive Role of ADC Value to ORADS in Adnexal Lesions

N/ACompletedNCT07202429

Cairo University66 enrolled

Overview

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 characterization using a combined O-RADS MRI/ADC mean reading approach.

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. Female patients with adnexal lesions on ultrasound were subjected to MRI examination, Standardised MRI sequences will used, including DWI and DCE sequences. blinded to histopathological data, according to the O-RADS MRI scoring system. A quantitative analysis method will applied by placing a ROI on the ADC maps obtained from single-exponential DWI sequences. Additive role of ADC value will be comparied to O-RADs according to gold standard (pathological examination of adnexal lesions) after excision to correlate results of imaging and pathology. MRI examination: MR imaging was performed using a 1.5-T magnet using torso coil Diffusion WI: with b values 0, 500, 1000 and 1500 as well as ADC map. Dynamic contrast enhanced study: using 10cc of Gadopentetate dimeglumine and 20ml of saline. Injection is manual. Examination time is 4minutes with 8 series. Scan time for each series: 32secs

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ovarian Neoplasms

Interventions

MRIDEVICE

"Multiparametric MRI of adnexal lesions, including conventional sequences, diffusion-weighted imaging (DWI) with apparent diffusion coefficient (ADC) measurement, and dynamic contrast-enhanced (DCE) MRI. Imaging findings were evaluated using the O-RADS MRI scoring system."

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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,……)

Locations (1)

Kasr Al-Ainy Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Outcomes

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

Data from ClinicalTrials.gov

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