Clinical trial · Observational
The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children
- 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)
When faced with an ovarian mass in a girl, conservative surgery (resection of the mass while preserving healthy ovarian tissue) via laparoscopy remains the most appropriate treatment option. However, this option is no longer indicated for malignant tumors, as this presents a risk of tumor dissemination that can significantly alter the child's subsequent prognosis. Therefore, for any malignant or suspected malignant tumor, radical treatment consisting of oophorectomy or salpingo-oophorectomy, often via laparotomy, is the standard. While keeping this therapeutic principle in mind, differentiating between benign and malignant entities remains the major challenge for clinicians. Furthermore, the diagnostic accuracy of the O-RADS classification based on MRI is not sufficiently established in the literature for children. Our project aims to conduct a multicenter study in the pediatric population to investigate the usefulness of this radiological classification in the preoperative diagnosis of ovarian masses.
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; Mastopathy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- O-RADS IRM (MRI)
- timeFrame
- Up to 9 months
- description
- Score Interpretation Risk O-RADS MRI 1 Normal 0% O-RADS MRI 2 Benign \< 1% O-RADS MRI 3 Probably Benign \~5% O-RADS MRI 4 Suspicious \~50% O-RADS MRI 5 Highly Suspicious \> 90%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Girls under 16 years of age. * Girls who underwent surgery for ovarian masses at the Pediatric Surgery Department of Mohammed VI University Hospital in Oujda during the study period. * Girls who underwent surgery for ovarian masses at the Pediatric Surgery Department of Strasbourg University Hospital during the study period. * Girls who underwent preoperative MRI. Exclusion Criteria: * Girls who underwent preoperative MRI. * Patients who did not undergo surgery. * Patients without histopathological examination of the surgical specimen. * Patients without MRI as a preoperative diagnostic evaluation modality.
References
Publications (0)
Data not yet available