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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean ADC value of adnexal lesions
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) Female patient any age with at least one adnexal lesion detected by U/S reported as O-RADS3to
- •(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.
排除标准
- •Female patient any age with adnexal lesions detected by U/S reported as O-RADS1and
- •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
- •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,……)
结局指标
主要结局
Mean ADC value of adnexal lesions
时间窗: March 2023 to june 2024
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)
Diagnostic performance of O-RADS MRI + ADC system
时间窗: March 2023 to june 2024
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 (%)
次要结局
未报告次要终点
研究者
Eman Badawy
Lecturer of Radiology, Cairo University
Cairo University