Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer With CA125 Elevation From Complete Response After Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
研究概览
简要总结
A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy
详细描述
Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven ovarian cancer with complete response after therapy
- •Age between 30 and 80
- •Elevation of serum CA125 value above the normal range (>35 U/mL) or doubling of serum CA125 value within the normal range
- •ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
- •Willing to enter this prospective study with signed informed consent form
排除标准
- •Patients with history of other malignancy
- •Patients who are pregnant or lactating
- •Patients with fasting fingerstick glucose level higher than 200 mg/dl
- •Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
- •Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators
结局指标
主要结局
Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
时间窗: 2 months for individual participants to complete all visits
Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4). Cancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study.
次要结局
- Overall Survival (OS)(5 years)
- Progression-free survival (PFS)(5 years)
研究者
Feng-Yuan Liu, MD
Principal Investigator
Chang Gung Memorial Hospital