MRI Assessment of Leukemia Response to Therapy
2019年7月27日 更新者：Wei Huang、OHSU Knight Cancer Institute
Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia
The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI) scan of the bone marrow before the start of standard chemotherapy can predict complete remission of leukemia patients after the therapy.
This type of MRI scan, called dynamic contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow.
For those patients who do not achieve complete remission status after initial therapy and will be treated with additional therapy, the investigators are also interested in determining if the second MRI exam before the additional therapy can predict complete remission.
If successfully tested, the MRI exam may be used in the future to help with early identification of patients who are unlikely to respond to standard chemotherapy.
This will allow for a personalized therapeutic plan to be developed for these patients at an early stage and prevent them from being exposed to toxic and ineffective therapies.
研究概览
研究类型
观察性的
注册 (实际的)
23
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。
学习地点
-
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health and Science University
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-
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
8年 至 75年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Primary Care Clinic
描述
Inclusion Criteria:
- Newly diagnosed or relapsed AML patients, who are scheduled to receive standard induction therapy.
- Age > 8 years and requiring no sedation.
- Patients must not be pregnant
- Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to start of study
- The subject or subject's legal guardian has the ability to understand and the willingness to sign a written informed consent and/or assent document. A signed study-specific informed consent and/or assent must be obtained prior to any study specific procedures.
Exclusion Criteria:
- Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
- Patients who have known or suspected allergy to gadolinium-based contrast agent.
- Severe claustrophobia precluding subject from undergoing a MRI
- Patients with acute or chronic kidney dysfunction (estimated Glomerular Filtration Rate (eGFR) < 30ml/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease (MDRD) Equation)
- Pregnant women are excluded from this study because of possible risk to the fetus.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Acute Myelogenous Leukemia (AML)
Patients who have been diagnosed with AML
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Each MR scanning session will include the pre-contrast multi-slice T2-weighted MRI with fat-saturation and T1-weighted MRI which are regularly acquired in clinical protocols.
Following these acquisitions, high-spatial and temporal-resolution DCE-MRI will be performed.
The total duration of a research MR session is expected to be less than 45 min.
其他名称：
|
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 |
|---|---|---|
|
Shutter-Speed Model
大体时间：Up to 1 year
|
To explore if Shutter-Speed Model (SSM) dynamic contrast-enhanced MRI (DCE-MRI)of the bone marrow (BM) can predict complete remission (CR) in newly diagnosed or relapsed acute myelogenous leukemia (AML)patients.
|
Up to 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pilot Data
大体时间：Up to 1 year
|
To collect pilot data in SSM DCE-MRI assessment of AML response to therapy for the conduct of future studies.
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Up to 1 year
|
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Complete Response
大体时间：Up to 1 year
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To explore whether SSM DCE-MRI differs in predicting complete response (CR) for the newly diagnosed AML patients and for the relapsed AML patients.
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Up to 1 year
|
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Second SSM DCE-MRI
大体时间：Up to 1 year
|
To explore if the second SSM DCE-MRI and/or changes between the first and second imaging studies can predict CR in the non-CR group who undergo an additional therapy.
|
Up to 1 year
|
|
DCE-MRI Biomarkers
大体时间：Up to 1 year
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To compare/correlate/combine DCE-MRI bio-markers with micro-vascular density (MVD) and proangiogenic cytokine profiles for the purpose of predicting response of AML patients to therapy.
|
Up to 1 year
|
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。
调查人员
- 首席研究员：Wei Huang, PhD、OHSU Knight Cancer Institute
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
2012年5月1日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2012年2月14日
首先提交符合 QC 标准的
2012年2月22日
首次发布 (估计)
2012年2月23日
研究记录更新
最后更新发布 (实际的)
2019年7月30日
上次提交的符合 QC 标准的更新
2019年7月27日
最后验证
2019年7月1日
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.