Non-invasive Detection of Cardiac Fibrosis After Administration of Doxorubicin-based Chemotherapy in Patients With Lymphoma Using Cardiac Magnetic Resonance
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Myocardial ECV
研究概览
简要总结
A study to test the effectiveness of an investigational imaging technique for detecting cardiac injury after the administration of certain chemotherapies, such as doxorubicin. "Investigational" means that the imaging technique is still being studied and that research doctors are trying to find out more about it- such as whether the technique can detect lower levels of cardiac injury after treatment with doxorubicin. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved the use of gadolinium or approved the use of CMR studies for detection of cardiac toxicity after doxorubicin.
The chemotherapy drug that you have been scheduled to be treated with, doxorubicin, has been associated with the development of heart failure in some patients. Cardiac Magnetic Resonance (CMR) is a type of MRI scan that uses a magnetic field to produce pictures of the heart. The CMR scan has been used in other studies and information from those other research studies suggest that this imaging technique may help to better detect differences in the structure of the heart muscle after treatment with doxorubicin. In this research study, we hope that we can better detect changes in the heart muscle after treatment with doxorubicin with a CMR scan in the hopes that cardiac injury can be detected and treated earlier to ultimately prevent the possible development of heart failure
详细描述
If you choose to take part in this study, we will ask you to sign this consent form before we do any study procedures. All participants will come in for a CMR scan prior to their first treatment with doxorubicin
- Visit 1 Visit 1 will take place prior to starting chemotherapy. The visit will take about 1.5 hours. We will ask you to come to the Shapiro Cardiovascular Center at the Brigham and Women's Hospital or Massachusetts General Hospital for your study visit.
For subjects that qualify, we will bring you for the heart CMR scan, an echocardiogram and some blood work.
Blood testing: Before your CMR scan we will take some blood via the IV cannula. We will take about 4 tubes of blood. This is equivalent to 2 ½ tablespoons of blood. From this blood we will test for blood markers of cardiac injury and compare these results to your other tests.
CMR Scan: For the CMR scan, you will be asked to lie still on the scanner table that slides into a tunnel-shaped machine. Four electrocardiogram (EKG) patches with wires attached will be placed on your chest or your back to check your heart rate. We will place an intravenous (IV) catheter in one of your arms. An IV catheter is a thin plastic tube that is put into a vein with a needle. The IV catheter will be used to give you a CMR contrast dye (gadolinium). The dye will help us to identify subtle changes within the heart muscle. This dye, gadolinium, is used routinely in CMR studies. We will also draw a sample of blood from the IV catheter to measure your red blood cell count. Then, the scanner table will move slowly into the tunnel-shaped CMR machine so the pictures can be taken. The machine is slightly wider than your body and there may be little room to move. If you feel any discomfort or need to stop the test, you will be able to tell this to the research staff. You will be able to speak to them while you are having the CMR and they will be able to speak to you. If you think that you might be too anxious about being inside the narrow CMR scanner for a long period of time, we may prescribe a drug called to help relax you if you think it might be helpful.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 and able to give consent
- •New diagnosis of lymphoma and scheduled to undergo doxorubicin (DOX)-based chemotherapy.
排除标准
- •Concurrent radiotherapy prior to the performance of both CMR studies, however consolidative radiotherapy after the completion of DOX and after the acquisition of the second CMR study is acceptable
- •No prior malignancy treated with chemotherapy or mediastinal radiotherapy
- •No contraindications to the performance of a magnetic resonance study:
- •The presence of an implanted metallic object such as a cardiac pacemaker or implantable defibrillator
- •An implanted neural stimulator
- •Any ferromagnetic implants not deemed MRI-safe
- •Intra-ocular metallic foreign bodies
- •Severe claustrophobia
- •Pregnancy
- •Inability to perform an exercise test
- •Glomerular filtration rate < 60 ml/min/1.73 m2
结局指标
主要结局
Myocardial ECV
时间窗: 2 Years
- To determine if a novel cardiac magnetic resonance-based index, the extracellular volume fraction (ECV), of myocardial fibrosis is altered early after doxorubicin-based chemotherapy.
次要结局
- Alteration of echocardiographic indices after doxorubicin-based chemotherapy(2 Years)
- Measurement of cardiopulmonary functional capacity(2 years)
- Alteration of serum biomarkers after doxorubicin based chemotherapy(2 years)
- Determine association between measurements pre- and post-doxorubicin-based chemotherapy(2 Years)
研究者
Tomas Neilan, MD
Principal Investigator
Massachusetts General Hospital