[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
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT
研究概览
简要总结
The goal of this clinical trial is to investigate the use of the tracer [68Ga]Ga-FAPI-46 for PET/CT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is:
• Can [68Ga]Ga-FAPI-46 PET/CT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker.
Researchers will compare findings on the experimental [68Ga]Ga-FAPI-46 PET/CT with findings on standard imaging ([18F]FDG PET/CT).
Participants will undergo:
- Two [68Ga]Ga-FAPI-46 PET/CT scans: one before treatment initiation with ICT and one after three months.
- Two blood samples
- Passive follow-up 6 months after the last scan [68Ga]Ga-FAPI-46 PET/CT
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
盲法说明
The baseline and the follow-up [68Ga]Ga-FAPI-46 PET/CT scan will be evaluated by a team of experienced specialists in clinical physiology and nuclear medicine, and radiology. These specialists are blinded from findings on the standard imaging ([18F]FDG PET/CT).
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
- •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
- •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
研究组 & 干预措施
Advanced staged Malignant Melanoma
Patients with advanced stage malignant melanoma with visible lesions on [18F]FDG PET/CT referred for ICT at the Dept. of Oncology Herlev Hospital will be sought enrolled. Patients will undergo two [68Ga]Ga-FAPI-46 PET/CT, which include injection with the experimental tracer [68Ga]Ga-FAPI-46. These scans are in addition to their standard imaging.
干预措施: [68Ga]Ga-FAPI-46 (Drug)
结局指标
主要结局
Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT
时间窗: From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months.
Specified malignant lesions will be defined and evaluated by a team of specialists on the baseline \[68Ga\]Ga- FAPI PET/CT scan and the uptake of the FAPI tracer in the lesions will be quantified. The evaluation of the malignant lesions on \[68Ga\]Ga-FAPI PET/CT will also be compared with a similar lesion evaluation on the \[18F\]FDG PET/CT (standard imaging). The FAPI-uptake will be reassessed after 12 weeks of ICT by the same team of specialists. Changes in uptake of malignant lesions after 12 weeks of ICT on the \[68Ga\]Ga-FAPI-46 PET/CT will be compared to changes on the \[18F\]FDG PET/CT and the clinical response. The clinical response will be assessed using the patients' medical record.
次要结局
- Changes in [68Ga]Ga-FAPI-46-uptake during ICT in healthy tissue(From enrollment in the study (signed informed consent) to the end of the follow-up (6 months after the second [68Ga]Ga-FAPI-46 PET/CT, estimated time in total is 9 months from signed informed consent).)
研究者
Barbara Malene Fischer
Professor, MD, Ph.D.
Rigshospitalet, Denmark