An observational study in Ovarian Cancer (OvCa) and Ovarian Cancer Metastatic, sponsored by Shanghai Gynecologic Oncology Group. Active, not recruiting at 1 site in China. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Shanghai Gynecologic Oncology Group · Observational
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 2,549 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Shanghai Gynecologic Oncology Group is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
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Patients with epithelial ovarian carcinoma (EOC) at FIGO stages I-IIB and stage IIIC (with a tumor burden score \<2).
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:
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)
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.
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).
Time frame: 2 years
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Gynecologic Oncology Group