[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative
研究概览
简要总结
Invasive squamous cell carcinoma (ISCC) represents 5 to 15% of breast cancers. Despite the rarity of this pathology, the number of patients with Invasive squamous cell carcinoma treated at HCL is significant.
Patients at risk of metastasis are usually referred to the HCL Nuclear Medicine departments to perform positron emission tomography - computed tomography (PET/CT) with [18]F-FDG as an extension assessment. We know that [18]F-FDG PET/CT has limited diagnostic performance for assessing the extent of breast cancer with a sensitivity of 66-96% for all histologies combined. For the ISCC, these performances are even lower with average Standard Uptake Value (SUV) values of 3.4 [2.8-3.9] versus 6.6 [4.8-9.7] for the others histological types of breast cancer. False negatives in [18]F-FDG PET/CT are due to an insufficient osteoblastic and immune response in the tumor stroma. Avril & al. showed 65.2% false negatives with [18]F-FDG PET/CT for ISCC. This is why the search for new imaging techniques in this indication is particularly relevant.
Targeting fibroblast activation protein (FAP), a type II membrane glycoprotein belonging to the dipeptidyl peptidase-4 family, is a promising strategy for imaging tumor stroma, particularly in epithelial carcinomas .
We would like to compare the [18]F-FDG PET/CT technique currently used to this new emerging modality.
We hypothesize superior diagnostic performance of [68]Ga-FAPI PET/CT compared to [18]F-FDG PET/CT for the assessment of ISCC extension, with a gold standard histological.
We translate this into the hypothesis of finding 30% of positive FAPI PET when the [18F]FDG PET/CT is negative or doubtful.
The advantage of this project and this new imaging modality is to not undertreat patients wrongly classified as non-metastatic. We therefore wish to offer [68]Ga-FAPI PET/CT to patients with negative [18]F-FDG PET/CT.
The FAPICL project constitutes a seed project before a larger structuring study.
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
- •Adult patient (≥18 years old),
- •Beneficiary or entitled to a social security system;
- •Patient having agreed to participate in the study and signed written informed consent;
- •18F-FDG PET/CT performed as part of the assessment of extension of an infiltrating lobular carcinoma, the result of which is negative or doubtful on at least one lesion.
排除标准
- •Pregnant, parturient or breastfeeding women. A pregnancy test before inclusion will be carried out for women of childbearing age.
- •Persons deprived of liberty by a judicial or administrative decision
- •People receiving psychiatric care
- •People admitted to a health or social establishment for purposes other than research
- •Adults subject to a legal protection measure (guardianship, curatorship)
- •Subjects participating in another interventional research including an exclusion period still ongoing at inclusion.
结局指标
主要结局
Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative
时间窗: 6 weeks
次要结局
- Average number per patient of lesions demonstrated in [68]Ga-FAPI, not seen in [18F]-FDG(6 weeks)
- Number of lesions positive on histology, among the lesions visualized on PET/CT with [68]Ga-FAPI (and in the case of negative histology, identify the differential diagnoses)(6 weeks)
- Evaluate the Positive Predictive Value of [68]Ga-FAPI PET/CT at the patient level, in patients negative on [18]F-FDG PET/CT(6 weeks)
- Analyze the semi-quantitative values of the PET signal by describing the [68Ga]-FAPI lesional SUVs, compared to the vascular and hepatic background(6 weeks)