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NCT07009743

O-RADS MRI System on Early Detection of Ovarian Cancer

Sponsor: Shanghai Gynecologic Oncology Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

35 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2549

Start Date

2025-01-01

Completion Date

2028-12-31

Last Updated

2025-06-08

Healthy Volunteers

No

Interventions

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.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, China, China