2023-503632-41-01招募中2 期
BEFAST STUDY: [68Ga]Ga-FAPI total body PET/CT for Better and Faster imaging in cancer Protocol: [68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 试验地点
- 1
- 主要终点
- 1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).
研究概览
简要总结
The overall aim of the study is to evaluate the diagnostic sensitivity of the tracer [68Ga]Ga-FAPI-46 with total body (TB) positron emission tomography (PET)/computed tomography (CT) compared to standard imaging in patients with gastroesophageal cancer and pancreatic cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for group A: 1)Male or female, =/>18 years old
- •Inclusion criteria for group B2: 1)Male or female, =/>18 years old
- •Inclusion criteria for group B2: 2)Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
- •Inclusion criteria for group B2: 3)Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
- •Inclusion criteria for group B2: 4)Subjects must be able to read and understand the patient information in Danish to give informed consent
- •Inclusion criteria for group A: 2)Patients with suspected pancreatic cancer based on morphological findings on standard imaging
- •Inclusion criteria for group A: 3)CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
- •Inclusion Criteria for group A: 4)Subjects must have been considered suitable for curative surgery at the time of the referral
- •Inclusion criteria for group A: 5)Subjects must be able to read and understand the patient information in Danish to give informed consent
- •Inclusion criteria for group B1: 1)Male or female, =/>18 years old
- •Inclusion criteria for group B1: 2)Histological verified carcinoma from the lower esophagus, GEJ, or stomach
- •Inclusion criteria for group B1: 3)Subjects must be considered operable and resectable at the time of referral for MDT
- •Inclusion criteria for group B1: 4)Subjects must be able to read and understand the patient information in Danish to give informed consent
排除标准
- •Exclusion criteria for group A+B: 1)Pregnancy or lactation
- •Exclusion criteria for group A+B: 2)Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
- •Exclusion criteria for group A+B: 3)History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
结局指标
主要结局
1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).
1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).
次要结局
- 1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT after 60 min, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV)
- 2) Estimated potential impact/change in patient management.
- 3) Description of FAPI-uptake from lesions suspicious of malignancy.
研究者
Barbara Malene Fischer
Scientific
Rigshospitalet
研究点 (1)
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