PET Imaging Study of 68Ga-FAPI-46 Biodistribution in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)
研究概览
简要总结
This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.
详细描述
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies measured by standardized uptake values (SUV).
SECONDARY OBJECTIVE:
I. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
OUTLINE:
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
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 suspected or diagnosed cancer types:
- •Adrenal cancer
- •Anal cancer
- •Bladder cancer
- •Brain cancer
- •Breast cancer
- •Cancer of unknown primary (CUP)
- •Cervical cancer
- •Cholangiocarcinoma
- •Colorectal cancer
- •Esophageal cancer
- •Gastric cancer
- •Head and neck cancer
- •Hematologic cancer
- •Hepatocellular carcinoma
- •Lung cancer
- •Medullary thyroid cancer
- •Neuroendocrine neoplasias
- •Ovarian cancer
- •Pancreatic cancer
- •Penile cancer
- •Peritoneal cancer
- •Pleural cancer
- •Prostate cancer
- •Salivary gland cancer
- •Solitary fibrous tumor
- •Skin cancer
- •Testicular cancer
- •Thymus cancer
- •Thyroid cancer
- •Urothelial cancer
- •Uterus cancer
- •Vaginal cancer
- •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
- •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
Diagnostic (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
干预措施: Gallium Ga 68 FAPi-46 (Radiation)
Diagnostic (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
干预措施: Computed Tomography (Procedure)
Diagnostic (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
干预措施: Fludeoxyglucose F-18 (Other)
结局指标
主要结局
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)
时间窗: Up to 2 years
Will be evaluated in normal and cancer tissues by standardized uptake values to determine where and to which degree 68Ga-FAPi-46 accumulates in normal and cancer tissues.
次要结局
- Fludeoxyglucose F-18 (18F-FDG) biodistribution(Up to 2 years)