BEFAST STUDY: [68Ga]Ga-FAPI total body PET/CT for Better and Faster imaging in cancer [68Ga]Ga-FAPI PET/CT for response evaluation during immune checkpoint inhibitor therapy in malignant melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT.
研究概览
简要总结
The overall aim of the study is to evaluate Total Body (TB) positron emission tomography/computed tomography (PET/CT) combined with the tracer [68Ga]Ga-FAPI-46 for response evaluation during immune checkpoint inhibitor therapy (ICT) in patients with advanced stage malignant melanoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, > 18 years old
- •Histological verified metastatic or locally advanced malignant melanoma
- •Visible malignant lesions on [18F]FDG PET/CT or CT
- •Subjects must be considered inoperable
- •Subjects must be considered medically suitable for ICT (either Pembrolizumab or Ipilimumab+Nivolumab)
- •Subjects must be able to read and understand the patient information in Danish to give informed consent
排除标准
- •Ocular or mucosal melanoma
- •Other concurrent cancer disease
- •Previous systemic oncological treatment with ICT
- •Pregnancy or lactation
- •Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
- •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
Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT.
Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT.
Evaluate changes in [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT.
Evaluate changes in [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT.
Compare the changes in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT with changes on standard [18F]FDG PET/CT and clinical response during ICT.
Compare the changes in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT with changes on standard [18F]FDG PET/CT and clinical response during ICT.
次要结局
- Changes in [68Ga]Ga-FAPI-46 uptake during ICT in healthy tissue as a predictor of potential side effects.
- Compare changes on [68Ga]Ga-FAPI-46 PET/CT in healthy tissue with changes on standard [18F]FDG PET/CT.
- Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP activity biomarkers in serum blood samples.
- Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of other biomarkers (e.g. ECM remodeling biomarkers) in serum blood samples.
- Correlation between levels of biomarkers in serum blood samples and treatment outcome.
研究者
Barbara Malene Fischer
Scientific
Rigshospitalet