Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease
2026年9月15日 更新者:Livia Kruger、Mayo Clinic
A Phase I Single Center Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease
The purpose of this research is to better understand the distribution of an investigational radioactive imaging agent called 68Ga-FAPI-46 in the lungs of people with interstitial lung disease (ILD) during a Positron Emission Tomography/Computed Tomography (PET/CT) scan.
研究概览
研究类型
介入性
注册 (估计的)
10
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Alicia Meek
- 电话号码:507-422-9699
- 邮箱:meek.alicia@mayo.edu
学习地点
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Clinical diagnosis of interstitial lung disease
- Radiologic lung abnormalities on diagnostic CT chest
- Anatomic imaging (clinical diagnostic CT chest) obtained within ≤ 180 days prior to the planned FAPI 46 imaging exam or within 14 days after the imaging exam.
- Willingness and ability to provide informed consent
Exclusion Criteria:
- Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
- Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
- Need for emergent surgery that would be delayed by participation
- Bacterial, viral, or fungal infections requiring systemic therapy
- Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives.
- No available chest CT radiological data
- No clear diagnosis of ILD
- Intolerability to perform the exam due to exuberant dyspnea or severely low pulmonary capacity.
- Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [68Ga]FAPI-46 injection.
- Known hypersensitivity to any excipients used in [68Ga]FAPI-46
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:⁶⁸Ga-FAPI-46 PET/CT
Subjects with interstitial lung disease will have a dose of 3 - 7 mCi (111 - 185MBq) of ⁶⁸Ga-FAPI-46 administered intravenously
|
Subjects will have 68Ga-FAPI-46 intravenously administered
Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Standardized Uptake Value in Abnormal Lung Parenchyma
大体时间:Approximately 1 hour post injection
|
Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in areas of abnormal lung parenchyma suggestive of interstitial lung disease
|
Approximately 1 hour post injection
|
|
Maximum Standardized Uptake Value in Normal Lung Parenchyma
大体时间:Approximately 1 hour post injection
|
Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in normal lung parenchyma
|
Approximately 1 hour post injection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Specificity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
大体时间:Baseline
|
Specificity will be calculated using diagnostic CT chest findings as the reference standard.
Specificity is defined as the proportion of participants without CT evidence of interstitial lung disease that are identified as negative on 68Ga-FAPI-46 PET/CT.
|
Baseline
|
|
Sensitivity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
大体时间:Baseline
|
Sensitivity will be calculated using diagnostic CT chest findings consistent with interstitial lung disease as the reference standard.
Sensitivity is defined as the proportion of participants with CT evidence of interstitial lung disease that are identified as positive on 68Ga-FAPI-46 PET/CT
|
Baseline
|
|
Accuracy of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
大体时间:Baseline
|
Accuracy will be calculated using diagnostic CT chest findings as the reference standard.
Accuracy is defined as the proportion of true positive and true negative 68Ga-FAPI-46 PET/CT findings among all evaluated findings.
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Livia F. Kruger, MD、Mayo Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月16日
初级完成 (估计的)
2030年5月1日
研究完成 (估计的)
2031年5月1日
研究注册日期
首次提交
2026年9月8日
首先提交符合 QC 标准的
2026年9月8日
首次发布 (实际的)
2026年9月14日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 25-009401
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.