NCT07009743

O-RADS MRI System on Early Detection of Ovarian Cancer

A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,549 (estimated)
• Sponsor: Shanghai Gynecologic Oncology Group · Other Government
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to prospectively enroll individuals with suspected or potential risk of ovarian cancer across multiple centers. The investigation will implement rational optimization of the recommended imaging sequences and interpretation protocols within the standard Ovarian-Adnexal Reporting and Data System (O-RADS) MRI framework. By integrating comprehensive clinical parameters and histopathological correlations, we aim to validate the diagnostic efficacy and reproducibility of the optimized protocol against the standard O-RADS MRI system. The ultimate objective is to establish a refined methodology for accurately diagnosing early-stage or low-burden ovarian malignancies, thereby improving prognostic outcomes of patients with ovarian cancer.

Conditions

• Ovarian Cancer (OvCa)
• Ovarian Cancer Metastatic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI contrast-enhancing agents	All patients underwent standard pelvic MRI examinations (1.5T or 3T) with the following sequences: T2-weighted imaging (T2WI), T1-weighted imaging (T1WI) with and without fat suppression; axial, sagittal, and coronal post-contrast T1WI following intravenous administration of gadolinium-based contrast agents (GBCA); functional sequences including dynamic contrast-enhanced MRI (DCE-MRI) and diffusion-weighted imaging MRI (DWI-MRI). Enhancement sequences may be omitted if no adnexal masses were identified on T2WI, T1WI, or DWI sequences.

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-06-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: China