A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,549
- 试验地点
- 1
- 主要终点
- the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer
时间窗: 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).
次要结局
未报告次要终点