O-RADS MRI System on Early Detection of Ovarian Cancer

NCT07009743 | Active Not Recruiting

• 1 other identifier: O-RADS MRI
• Study Type: observational
• Target: 2,549
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  To evaluate the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer (FIGO stages I-IIIC, epithelial ovarian carcinoma \[EOC\], tumor burden score ≤2), including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC).

  2 years

Interventions

MRI contrast-enhancing agents DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 35 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with epithelial ovarian carcinoma (EOC) at FIGO stages I-IIB and stage IIIC (with a tumor burden score \<2).

You may qualify if:

• 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:
• 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.
• ② Ability to comply with the study protocol and adhere to scheduled follow-up assessments.
• ③ Provision of written informed consent.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Gynecologic Oncology Group: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China, 200032, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

CN (1)