An observational study in Ovarian Neoplasms, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Cairo University · Observational
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
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 66 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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female patients any age with ovarian lesions
(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:
Contraindications to MRI examination including
Description: Participants with adnexal lesions that were confirmed as benign on histopathology. Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) measurement, used for lesion characterization with O-RADS scoring.
Device: MRI
Description: Participants with adnexal lesions that were confirmed as borderline on histopathology. Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and ADC measurement, used for lesion characterization with O-RADS scoring.
Device: MRI
Description: Participants with adnexal lesions that were confirmed as maligannt on histopathology. Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and ADC measurement, used for lesion characterization with O-RADS scoring.
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."
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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Cairo University