PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues
研究概览
简要总结
This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.
详细描述
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.
SECONDARY OBJECTIVES:
I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with the following cancer types:
- •Brain cancer
- •Bladder cancer
- •Urothelial cancer
- •Testicular cancer
- •Skin cancer
- •Thyroid cancer
- •Hepatocellular carcinoma
- •Cholangiocarcinoma
- •Thymus cancer
- •Pleural cancer
- •Cervical cancer
- •Adrenal cancer
- •Neuroendocrine tumors
- •Hematologic cancer
- •Cancer of Unkown Primary
- •Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
- •Patients are ≥ 18 years old at the time of the radiotracer administration.
- •Patient can provide written informed consent
- •Patient is able to remain still for duration of imaging procedure (up to one hour)
排除标准
- •Patient is pregnant or nursing
- •Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT
- •Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data
研究组 & 干预措施
Basic science (68GA-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
干预措施: Computed Tomography (Procedure)
Basic science (68GA-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
干预措施: Gallium Ga 68 FAPi-46 (Drug)
Basic science (68GA-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
干预措施: Positron Emission Tomography (Procedure)
Basic science (68GA-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
干预措施: 18F-FDG (Radiation)
结局指标
主要结局
Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues
时间窗: At 20-90 minutes after injection]
Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).
次要结局
- 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)(Up to year 2)
- 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution(up to 2 years)