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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benign Adnexal Lesions | 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. |
| |
| Borderline adnexal lesions | 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. |
| |
| Malignant adnexal lesions | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | "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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 (%) | March 2023 to june 2024 |
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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:
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
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female patients any age with ovarian lesions
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| Name | Affiliation | Role |
|---|---|---|
| Lamia Salah Eldin, M.D | kasr-alainy cairo university | Principal Investigator |
| Manar Alaa Eldin Osman, M.D | kasr-alainy cairo university | Study Director |
| Mohammed Aly Shalaby, M.D | kasr-alainy cairo university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-Ainy Faculty of Medicine, Cairo University | Cairo | Cairo Governorate | 11562 | Egypt |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |