接受化疗的患者对 18F Florbetapir 的心脏摄取
在接受化疗的患者中评估 18F Florbetapir 与心脏淀粉样蛋白结合的初步研究
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 年龄 > 18 岁的患者符合条件。
- 患者必须提供知情同意才能参与研究方案。
- 所有患者都必须有心脏 AL 淀粉样变性的临床诊断(典型的超声心动图或心脏 MRI 结果、NT-ProBNP 水平高于 332 pg/mL、轻链淀粉样变性的心脏或心脏外组织学证据)。
- 计划的浆细胞定向化疗。
- 所有有生育能力的女性都需要进行阴性妊娠试验,不允许母乳喂养。
- 患者必须能够接受 PET-CT 成像
- 患者必须能够完成 6 分钟步行测试
排除标准:
- 严重的幽闭恐惧症
- 怀孕
- 对 F-18 florbetapir 过敏
学习计划
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:AL 心脏淀粉样蛋白患者
入组患者年龄 > 18 岁,临床诊断为心脏 AL 淀粉样变性(典型的超声心动图或 MRI 结果,NT-ProBNP 水平高于 332 pg/mL,轻链淀粉样变性的心脏或心脏外组织学证据)并计划接受浆细胞定向化疗。
|
接受计划的浆细胞定向化疗的心脏淀粉样变性 (AL) 患者将在开始化疗前和治疗开始后六个月进行 F-18 florbetapir (amyvid) 心脏 PET/CT 成像。
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 |
|---|---|---|
|
Relative Change in Cardiac Uptake of 18F Florbetapir Prior to Chemotherapy and After Six Months of Chemotherapy.
大体时间:six months
|
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
|
six months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Six Minute Walk Test
大体时间:twelve months
|
Change in Distance covered on six minute walk test at onset of chemotherapy will be compared to distance covered after six months of chemotherapy Distance at onset vs six months will be correlated with changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months.
Overall change in distance walked during 6 minute walk prior to starting chemotherapy and after 12 months of chemotherapy will be compared to any changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months.
|
twelve months
|
|
Hematologic Response
大体时间:12 months
|
correlation of hematologic response to treatment at 6 months and 18F florbetapir cardiac uptake changes between 0 and 6 months.
Hematologic response after 12 months will also be compared to any changes in 18F florbetapir cardiac uptake between 0 and 6 months.
|
12 months
|
|
Cardiac Response
大体时间:12 months
|
Cardiac response as defined by changes in NT proBNP (N Terminal proBNP) levels and cardiac Troponin T levels will be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months.
Changes in Cardiac troponin T and NT pro BNP levels after 12 months will also be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months.
|
12 months
|
|
Patient Related Outcomes
大体时间:12 months
|
Correlation of hematologic response to results of patient related outcomes survey completed at 0, 6, and 12 months. Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely. |
12 months
|
|
Patient Related Outcomes
大体时间:12 months
|
Correlation of cardiac response to results of patient related outcomes survey completed at 0, 6, and 12 months Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely. |
12 months
|
|
Patient Related Outcomes
大体时间:12 months
|
Correlation changes in 18F florbetapir cardiac uptake between 0 and 6 months to results of patient related outcomes survey completed at 0, 6, and 12 months Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely. |
12 months
|
合作者和调查者
调查人员
- 首席研究员:Chris Mueller, MD、Medical College of Wisconsin
出版物和有用的链接
一般刊物
- Merlini G, Bellotti V. Molecular mechanisms of amyloidosis. N Engl J Med. 2003 Aug 7;349(6):583-96. doi: 10.1056/NEJMra023144. No abstract available.
- Esplin BL, Gertz MA. Current trends in diagnosis and management of cardiac amyloidosis. Curr Probl Cardiol. 2013 Feb;38(2):53-96. doi: 10.1016/j.cpcardiol.2012.11.002.
- Dorbala S, Vangala D, Semer J, Strader C, Bruyere JR Jr, Di Carli MF, Moore SC, Falk RH. Imaging cardiac amyloidosis: a pilot study using (1)(8)F-florbetapir positron emission tomography. Eur J Nucl Med Mol Imaging. 2014 Sep;41(9):1652-62. doi: 10.1007/s00259-014-2787-6. Epub 2014 May 20.
- Osborne DR, Acuff SN, Stuckey A, Wall JS. A Routine PET/CT Protocol with Streamlined Calculations for Assessing Cardiac Amyloidosis Using (18)F-Florbetapir. Front Cardiovasc Med. 2015 May 8;2:23. doi: 10.3389/fcvm.2015.00023. eCollection 2015.
- Lister-James J, Pontecorvo MJ, Clark C, Joshi AD, Mintun MA, Zhang W, Lim N, Zhuang Z, Golding G, Choi SR, Benedum TE, Kennedy P, Hefti F, Carpenter AP, Kung HF, Skovronsky DM. Florbetapir f-18: a histopathologically validated Beta-amyloid positron emission tomography imaging agent. Semin Nucl Med. 2011 Jul;41(4):300-4. doi: 10.1053/j.semnuclmed.2011.03.001.
- Park MA, Padera RF, Belanger A, Dubey S, Hwang DH, Veeranna V, Falk RH, Di Carli MF, Dorbala S. 18F-Florbetapir Binds Specifically to Myocardial Light Chain and Transthyretin Amyloid Deposits: Autoradiography Study. Circ Cardiovasc Imaging. 2015 Aug;8(8):10.1161/CIRCIMAGING.114.002954 e002954. doi: 10.1161/CIRCIMAGING.114.002954.
- Sikkink LA, Ramirez-Alvarado M. Cytotoxicity of amyloidogenic immunoglobulin light chains in cell culture. Cell Death Dis. 2010 Nov 11;1(11):e98. doi: 10.1038/cddis.2010.75.
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 29197
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.