Cardiac Fibrosis by CMR in Patients With Cancer
| Status: | Withdrawn |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/16/2018 |
| Start Date: | March 2013 |
| End Date: | August 25, 2018 |
Non-invasive Detection of Cardiac Fibrosis After Administration of Doxorubicin-based Chemotherapy in Patients With Lymphoma Using Cardiac Magnetic Resonance
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
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
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.
The CMR scan will take one hour.
Echocardiogram: An echocardiogram is a test used by doctors to monitor heart function. An
echocardiogram is a safe test that uses ultrasound to image the heart. After completion of
the CMR test, you will have an echocardiogram. This test will take place in the same area as
the CMR test. The echocardiogram test will take 40 minutes.
- Visit 2: Visit 2 will take place about 2-4 weeks after your last cycle of doxorubicin
chemotherapy.
When you come back for Visit 2, you will have the same type of CMR scan, echocardiogram and
blood testing that you had during Visit 1.
- Visit 3: At visit three we will perform an exercise test on a bicycle. The test is designed
to test the oxygen consumption of your body when exercising. It provides a way of quantifying
the ability of the body to exercise. This test will take 30 minutes. During this test
subjects sit on the bicycle for at least 3 minutes pedaling at a rate of 60 cycles per minute
and slowly the work-load is increased until peak exercise is obtained. We define peak
exercise as being tired or breathless. Heart rate and blood pressure are recorded during the
test. During the test you will breathe through a mouthpiece from which we will measure oxygen
levels.
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.
The CMR scan will take one hour.
Echocardiogram: An echocardiogram is a test used by doctors to monitor heart function. An
echocardiogram is a safe test that uses ultrasound to image the heart. After completion of
the CMR test, you will have an echocardiogram. This test will take place in the same area as
the CMR test. The echocardiogram test will take 40 minutes.
- Visit 2: Visit 2 will take place about 2-4 weeks after your last cycle of doxorubicin
chemotherapy.
When you come back for Visit 2, you will have the same type of CMR scan, echocardiogram and
blood testing that you had during Visit 1.
- Visit 3: At visit three we will perform an exercise test on a bicycle. The test is designed
to test the oxygen consumption of your body when exercising. It provides a way of quantifying
the ability of the body to exercise. This test will take 30 minutes. During this test
subjects sit on the bicycle for at least 3 minutes pedaling at a rate of 60 cycles per minute
and slowly the work-load is increased until peak exercise is obtained. We define peak
exercise as being tired or breathless. Heart rate and blood pressure are recorded during the
test. During the test you will breathe through a mouthpiece from which we will measure oxygen
levels.
Inclusion Criteria:
- Aged ≥ 18 and able to give consent
- New diagnosis of lymphoma and scheduled to undergo doxorubicin (DOX)-based
chemotherapy.
Exclusion Criteria:
- 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
We found this trial at
3
sites
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Tomas Neilan, MD
Phone: 617-726-2677
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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