Clinical trial · Observational
Additive Role of ADC Value to ORADS in Adnexal Lesions
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
NCT07202429CI-TRIAL-00096090completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Benign Adnexal Lesions
- description
- 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.
- interventionNames
- Device: MRI
- label
- Borderline adnexal lesions
- description
- 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.
- interventionNames
- Device: MRI
- label
- Malignant adnexal lesions
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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,……)
References
Publications (0)
Data not yet available
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