The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07313514

Acronym

MMO

Enrollment

100

Registered

2026-01-02

Start date

2025-03-11

Completion date

2026-02-28

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian; Mastopathy

Keywords

Malignancy in Ovarian Masses, Ovarian; Mastopathy

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
O-RADS IRM (MRI)	Up to 9 months	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%

Countries

France

Contacts

Primary ContactIsabelle TALON, MD, PhD

Isabelle.TALON@chru-strasbourg.fr33 3 88 12 72 96

Outcome results