Zhongshan Hospital, Fudan University
Shanghai, China, 200032
NCT Number: NCT07009743
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.
This study is active but is not currently recruiting participants.
Notify Me35 year and older
Female
Observational
Shanghai, China, 200032
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
② Ability to comply with the study protocol and adhere to scheduled follow-up assessments.
③ Provision of written informed consent.
Exclusion criteria
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.
Time frame: 2 years
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).
Shanghai Gynecologic Oncology Group
Other Gov
A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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