O-RADS MRI classification to predict malignancy of ovarian masses in girls
Official title: The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children
Run by University Hospital, Strasbourg, France · NCT07313514 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Year to 16 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | March 11, 2025 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07313514 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
-
Comparing oral and transdermal estrogen therapy in women with Turner syndrome
This study is testing whether taking estrogen as a pill or through the skin is better for women with Turner syndrome in terms of their overall health and well-being.
-
Comparing oral and transdermal estrogen treatment in women with Turner syndrome
This study is testing whether taking estrogen by mouth or through the skin works better for women with Turner syndrome.
-
Investigating the link between HIV infection and male hypogonadism
This study looks at how common low testosterone is in men with HIV compared to men without HIV to see what factors might be linked to it.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
CR-002 study in adults with advanced solid tumors
This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.