NCT07202429

Additive Role of ADC Value to ORADS in Adnexal Lesions

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

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. 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

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DEVICE	MRI	"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."

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-06-01
• Completion: 2025-01-01
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: Egypt