NCT07202429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 6, 2023

Last Update Submit

September 29, 2025

Conditions

Ovarian Neoplasms

Keywords

MRI-ORADSADC valueOvarian neoplasms

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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.

Device: MRI

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.

Device: MRI

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.

Device: MRI

Interventions

MRIDEVICE

"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."

Benign Adnexal LesionsBorderline adnexal lesionsMalignant adnexal lesions

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

female patients any age with ovarian lesions

You may qualify if:

  • (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.

You may not qualify if:

  • 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
  • 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,……)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al-Ainy Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Radiology, Cairo University

Study Record Dates

First Submitted

September 6, 2023

First Posted

October 1, 2025

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

January 1, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

EG(1)