用于诊断儿童造血干细胞移植后闭塞性细支气管炎综合征的新型肺功能指标
In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Ontario
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Toronto、Ontario、加拿大、M5G 1X8
- The Hospital for Sick Children
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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
取样方法
研究人群
Two groups of participants will be recruited. Group 1 will be participants who meet the screening criteria for the development of BOS according to the NIH criteria. Group 2 will be participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS.
描述
Inclusion Criteria:
- Male and female participants aged 6 -17.9 years old.
- Received HSCT treatment at least 6 months prior to enrollment in study.
- Participants should have an FEV1%pred value greater than 40%.
- Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
- Participant must be able to perform a breath hold for 16s.
- Participant meets MRI screening criteria
Exclusion Criteria:
- Participant has had a cold or respiratory infection in the last four weeks.
- Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
- Participant is unable to perform spirometry or plethysmography maneuvers.
- Participant is pregnant or lactating.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Group 1
Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria |
|
Group 2
Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS |
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 |
|---|---|---|
|
Assessment of MRI
大体时间：24 months
|
Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria. |
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation
大体时间：24 months
|
Correlate MRI with conventional breathing tests |
24 months
|
合作者和调查者
调查人员
- 首席研究员：Giles Santyr, PhD、The Hospital for Sick Children
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
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.