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NCT Number: NCT07313514

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

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.

Recruiting

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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Houssain BENHADDOU, MD, PhD

PRINCIPAL_INVESTIGATOR

Isabelle TALON, MD, PhD

CONTACT

[email protected]

33 3 88 12 72 96

Isabelle TALON, MD, PhD

PRINCIPAL_INVESTIGATOR

Kamal EL HAISSOUFI, MD

SUB_INVESTIGATOR

Shaima AL SUDAIRI, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. O-RADS IRM (MRI)

    Time frame: 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%

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle TALON, MD, PhD

CONTACT

[email protected]

33 3 88 12 72 96

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: MMO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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