O-RADS MRI classification to predict malignancy of ovarian masses in girls
The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children
This project will test whether the O-RADS MRI classification can help doctors tell if ovarian masses in girls under 16 are benign or malignant before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07313514 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study will include girls under 16 who had preoperative MRI and surgical removal of an ovarian mass at participating pediatric surgery departments in Strasbourg and Oujda. Radiologists will assign O-RADS scores to the preoperative MRIs and those scores will be compared with the histopathology results from the surgical specimens. The study will calculate diagnostic accuracy measures (sensitivity, specificity, predictive values) and examine whether O-RADS can reliably distinguish benign from malignant lesions in children. Results will inform whether O-RADS MRI classification can be used to guide decisions between conservative, fertility-sparing surgery and more radical procedures.
Who should consider this trial
Good fit: Girls under 16 who had an ovarian mass, underwent preoperative MRI, and had surgical removal with histopathological examination at one of the participating pediatric centers.
Not a fit: Girls without preoperative MRI, those who did not undergo surgery with pathology, or patients older than the inclusion age are unlikely to benefit from this work.
Why it matters
Potential benefit: If successful, this could help surgeons choose fertility-sparing operations for girls with benign lesions and avoid unnecessary radical surgery.
How similar studies have performed: O-RADS has shown usefulness in adult populations for predicting ovarian malignancy, but pediatric-specific evidence is limited and the approach remains relatively untested in children.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Strasbourg
- Service de Chirurgie Pédiatrique - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Isabelle TALON, MD, PhD
- Email: Isabelle.TALON@chru-strasbourg.fr
- Phone: 33 3 88 12 72 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.