Additive Role of ADC Value to ORADS in Adnexal Lesions

NCT ID: NCT07202429

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-01-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MRI

Intervention Type: 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."

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.

MRI

Intervention Type: 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."

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.

MRI

Intervention Type: 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."

Interventions

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."

Intervention Type: DEVICE

Eligibility Criteria

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,……)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Badawy

Lecturer of Radiology, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lamia Salah Eldin, M.D

Role: PRINCIPAL_INVESTIGATOR

kasr-alainy cairo university

Manar Alaa Eldin Osman, M.D

Role: STUDY_DIRECTOR

kasr-alainy cairo university

Mohammed Aly Shalaby, M.D

Role: STUDY_CHAIR

kasr-alainy cairo university

Locations

Kasr Al-Ainy Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

mri dwi in adnexal lesions

Identifier Type: -

Identifier Source: org_study_id