2025-524897-40-00招募中2 期
[68]GA-FAPI-46 PET/CT for the diagnosis of metastatic lesions in patients with lobular breast cancer (ICL). FAPICL
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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 detected with [68]Ga-FAPI and confirmed by histology, when the [18]F-FDG PET/CT is negative.
研究概览
简要总结
Assessment of the proportion of patients for whom a secondary lesion is detected on [68]Ga-FAPI (confirmed by histology or the composite reference standard), when the [18]F-FDG PET/CT is negative or uncertain for regional or distant disease spread.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 scheme
- •Patient who has agreed to participate in the study and signed a written informed consent
- •PPET/CT with 18F-FDG performed as part of the initial staging or restaging of a recurrence or progression of an invasive lobular carcinoma, with results that are negative or uncertain for at least one lesion.
- •For patients of childbearing potential, highly effective contraception for the duration of study participation. A blood pregnancy test will be performed at inclusion.
排除标准
- •Pregnant, laboring, or breastfeeding women
- •Persons deprived of liberty by a judicial or administrative decision -Persons undergoing psychiatric care
- •People admitted to a healthcare or social institution for purposes other than research
- •Adults subject to a legal protection measure (guardianship, curatorship)
- •Subjects participating in another interventional study including an exclusion period still in progress at inclusion.
- •Presenting a contraindication to PET (claustrophobia)
- •People receiving psychiatric care
结局指标
主要结局
Percentage of patients for whom at least one secondary lesion is detected with [68]Ga-FAPI and confirmed by histology, when the [18]F-FDG PET/CT is negative.
Percentage of patients for whom at least one secondary lesion is detected with [68]Ga-FAPI and confirmed by histology, when the [18]F-FDG PET/CT is negative.
次要结局
- Average number per patient of lesions detected with [68]Ga-FAPI, not seen on [18F]-FDG. This criterion will be collected at the time of the imaging review by a nuclear medicine physician.
- Number of positive lesions in histology, among the lesions visualized in PET/CT with [68]Ga-FAPI (and in case of negative histology, identify the differential diagnoses). This criterion will be collected at the time of publication of the histological report of the detected suspicious lesion.
- This criterion will be collected and compared at the time of the publication of the histological report of the detected suspicious lesion and between the 2 PET scans.
- The values of SUVmax lesion, SUVmax liver, SUVmax aorta will be collected at the time of the imaging interpretation by a nuclear medicine physician, for each suspicious lesion.
- Estimate the number of lesions detected by PET/CT with [68]Ga-FAPI and not detected by PET/CT with [18]F-FES in our study population.
- Estimate the number of lesions detected on PET/CT with [18]F-FES and not detected on PET/CT with [68]Ga-FAPI in our study population
研究者
Dr Nicolas JACQUET-FRANCILLON
Scientific
Hospices Civils De Lyon
研究点 (1)
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