FAPI PET in Systemic Sclerosis Interstitial Lung Disease
PHASE II OPEN-LABEL EFFICACY AND SAFETY STUDY OF FIBROBLAST ACTIVATION PROTEIN α (FAP)-DIRECTED RADIOTRACER 68Ga-FAPI-46 AS A POSITRON EMISSION TOMOGRAPHY (PET) FUNCTIONAL RESPONSE BIOMARKER FOR SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
This is a phase II open-label efficacy and safety study to evaluate standard of care treatment response measured by PET imaging radiotracer 68Ga-FAPI-46 in 120 subjects with SSc-ILD.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Nahal E Ghanoongooi, CRC, MPH
- 电话号码：310-794-1638
- 邮箱：nghanoongooi@mednet.ucla.edu
学习地点
-
-
California
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Los Angeles、California、美国、90095
- UCLA Division of Rheumatology
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ability to provide written informed consent.
- Male or female > 18 years of age at the screening visit.
- Meets the 2013 American College of Rheumatology (ACR)/EULAR Classification Criteria for SSc.
- ILD confirmed by thoracic high resolution computed tomography (HRCT) at the baseline visit.
- Initiated or will initiate a new ILD therapy within the last 3 months +/- 1 week prior to the screening visit.
- If enrolled in the FAPI/PET group, women of child-bearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnant test will be required.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study.
- Active infectious lung disease.
- Current malignancy other than squamous or basal cell carcinoma.
- Current lung disease other than ILD (e.g., emphysema).
- Subjects must not have participated in another clinical trial with an investigational product within 90 days prior to enrollment and agree to abstain from such trials during the study.
- Prior allergic reaction to radiotracer 68Ga-FAPI-46.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 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：Receive PET Scan
|
68Ga-FAPI-46 will be used for the PET/CT for SSc ILD patients |
|
无干预：Blood Draw Only
|
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 |
|---|---|---|
|
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in uptake of radiotracer 68Ga-FAPI-46
大体时间：1 year
|
This endpoint will evaluate whether the change in uptake of radiotracer 68Ga-FAPI-46 from baseline to 6 months of treatment predicts progressive pulmonary fibrosis (PPF) at 1 year according to American Thoracic Society guidelines. |
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in the levels of specific blood-based biomarkers
大体时间：1 year
|
This endpoint will evaluate whether the change in circulating biomarkers levels at 6 months predicts PPF at 1 year using the same definition above. |
1 year
|
合作者和调查者
调查人员
- 首席研究员：Elizabeth Volkmann, MD, MS、University of California, Los Angeles
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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