Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of lesions detected by 18F-FAPI-74 PET/CT
研究概览
简要总结
This study is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). Patients will undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT within a 2-week period (14 days + 7 days) to compare lesions, tumor detection rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- •Females; Age > 18 years of age
- •Diagnosis of invasive lobular breast cancer, with pathologically confirmed metastatic disease.
- •ECOG performance status 0-2
- •No planned change in anticancer therapy between FDG and FAPI PET scans
排除标准
- •Patients who are pregnant or lactating
- •Patients who cannot undergo PET/CT scanning
- •Patients with total serum bilirubin or serum creatinine > 1.5 times the upper limit of normal
研究组 & 干预措施
18F-FAPI-74 PET/CT and 18F-FDG PET/CT
Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.
干预措施: PET/CT (Procedure)
18F-FAPI-74 PET/CT and 18F-FDG PET/CT
Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.
干预措施: 18F-FDG (Drug)
18F-FAPI-74 PET/CT and 18F-FDG PET/CT
Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.
干预措施: 18F-FAPI-74 (Drug)
结局指标
主要结局
Proportion of lesions detected by 18F-FAPI-74 PET/CT
时间窗: End of study, at 1 month
Proportion of lesions detected by 18F-FAPI-74 PET/CT but not by 18F-FDG PET/CT. All lesions will be mapped across both imaging modalities to determine whether they were detected by FAPI PET/CT but not by FDG PET/CT.
次要结局
- Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT(End of study, at 1 month)
- Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT(End of study, at 1 month)
- Tumor detection rate(End of study, at 1 month)
- SUVmax of the hottest lesion (lesion with highest SUVmax) on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT and mean SUVmax across all lesions(End of study, at 1 month)
- Tumor-to-background ratio (TBR)(End of study, at 1 month)
- Number of participants with change in therapeutic management decisions(End of study, at 1 month)
- Change in disease status assessment(End of study, at 1 month)
研究者
Randy Yeh
Associate Professor
Icahn School of Medicine at Mount Sinai