Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of positive tumor lesions, i.e. confirmed by additional imaging, histopathology/biopsy or response to treatment (on imaging or clinical assessment)
研究概览
简要总结
Lobular Breast cancer staging with 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is not optimal due to the poor accumulation of 18F-FDG in the tumour. Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET.
详细描述
Research hypothesis : Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET. Participants with lobular breast carcinoma will then undergo 18F-FDG and 68Ga-FAPI-46 PET scan.
Primary objective of the study is to compare the sensitivity of 68Ga-FAPI-46 with the sensitivity of 18F-FDG in the detection of lobular breast carcinoma lesions, measured by positron emission tomography (PET). These results will be compared with the histological data collected before or during surgery (conventional histological data and immunohistochemical labeling of FAPα on the sample obtained), clinical follow-up and any results of additional examinations carried out within the usual clinical follow-up of the patients.
Comparison of primary tumor and metastases uptake of 68Ga-FAPI-46 with the uptake of 18F-FDG, radiomic study of 68Ga-FAPI-46 PET and comparative radiomic study of 68Ga-FAPI-46 PET and 18F-FDG PET and comparison of the specificity of 68Ga-FAPI-46 with the specificity of 18F-FDG after a 12-month follow-up will also be performed as secondary objectives.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •ECOG from 0 to 2
- •Histological diagnosis of Lobular Carcinoma of the breast based on a breast biopsy
- •Patient naïve to any treatment for lobular breast carcinoma
- •Women of childbearing age should have an adequate method of contraception
- •Patient having voluntarily accepted to participate in the study and signed the informed consent
- •Minimum tumor stage IIA
- •Sufficient histological material in the biopsy or the surgical specimen, if the biopsy is insufficient
排除标准
- •PET scan contraindications: severe claustrophobia, unbalanced diabetes during 18F-FDG PET scans (fasting capillary blood sugar ≥ 11 mmol)
- •Hormone therapy started
- •18F-FDG PET scan > 21 days
- •Pregnant women, parturients and nursing mothers
- •Persons deprived of liberty by a judicial or administrative decision
- •Persons admitted to a health or social establishment for purposes other than research
- •Adults who are the subject of a legal protection measure or who are unable to express their consent
研究组 & 干预措施
68Ga-FAPI-46 PET scan + 18-FDG PET scan
干预措施: 68Ga-FAPI-46 PET scan (Diagnostic Test)
结局指标
主要结局
Number of positive tumor lesions, i.e. confirmed by additional imaging, histopathology/biopsy or response to treatment (on imaging or clinical assessment)
时间窗: Up to 12 months
Number of positive tumor lesions of 68Ga-FAPI-46 PET scan in comparison with 18F-FDG PET scan
次要结局
- MTVFAPI and MTVFDG (Metabolic Tumor Volume)(Up to 21 days)
- Molecular biology analysis of tumor samples(12 months)
- Correlation between PET scan and breast histology(Up to 12 months)
- Specificity comparison(12 months)
- SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)(Up to 21 days)
- SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios(Up to 21 days)
- Correlation between PET scan and FAPα labeling(Up to 12 months)
- Number of discrepancies between FAPI and FDG PET scans(Up to 21 days)
- Correlation between tumor lesion radiomics and histological characteristics(12 months)