O-RADS MRI System on Early Detection of Ovarian Cancer

NCT ID: NCT07009743

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2549 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients meeting either of the following criteria based on initial diagnostic pelvic ultrasound findings (pelvic mass or pelvic effusion) suspicious for ovarian malignancy or at elevated risk for ovarian cancer:

1. Postmenopausal women or females ≥45 years with pelvic mass or effusion on ultrasound;

2. Postmenopausal women or females ≥45 years with serum CA125 ≥35 U/mL;

3. Females ≥35 years with a confirmed family history of ovarian or breast carcinoma;

4. Females ≥35 years harboring pathogenic/likely pathogenic BRCA1/2 germline mutations;

5. Females ≥35 years with BRCA1/2 mutations, non-suspicious adnexal lesions on ultrasound but planning prophylactic adnexectomy with availability of serial pathological sectioning.

② Ability to comply with the study protocol and adhere to scheduled follow-up assessments.

③ Provision of written informed consent.

Exclusion Criteria

• ① Pregnant individuals

• Patients with histopathologically confirmed ovarian cancer

• Ovarian malignancy diagnosed by PET-CT at this institution

④ Patients undergoing neoadjuvant chemotherapy for confirmed ovarian cancer

⑤ Claustrophobia precluding tolerance of MRI examination

⑥ Contraindications to MRI: cardiac pacemakers, ferromagnetic implants, or high-risk metallic foreign bodies

⑦ History of gadolinium-based contrast agent (GBCA) hypersensitivity or intolerance

⑧ Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 m²)

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Gynecologic Oncology Group

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, China, China

Countries

China

Other Identifiers

O-RADS MRI

Identifier Type: -

Identifier Source: org_study_id