Active — Not RecruitingNot Applicable

O-RADS MRI System on Early Detection of Ovarian Cancer

China2,549 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range35 Years

SexFEMALE

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Inclusion criteria

✓. Postmenopausal women or females ≥45 years with pelvic mass or effusion on ultrasound;
✓. Postmenopausal women or females ≥45 years with serum CA125 ≥35 U/mL;
✓. Females ≥35 years with a confirmed family history of ovarian or breast carcinoma;
✓. Females ≥35 years harboring pathogenic/likely pathogenic BRCA1/2 germline mutations;
✓. Females ≥35 years with BRCA1/2 mutations, non-suspicious adnexal lesions on ultrasound but planning prophylactic adnexectomy with availability of serial pathological sectioning.

What they're measuring

the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer

Timeframe: 2 years

Trial details

NCT IDNCT07009743

SponsorShanghai Gynecologic Oncology Group

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Ovarian Cancer (OvCa) trials