Detection of Cardiac Fibrosis in Patients With Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2012 |
| Contact: | Michael Jerosch-Herold, PhD |
| Email: | mjerosch-herold@partners.org |
| Phone: | 6175258959 |
Non-invasive Detection of Cardiac Fibrosis After Administration of Doxorubicin-Based Chemotherapy in Patients With Lymphoma Using Cardiac Magnetic Resonance: A Pilot Study
This research study is a clinical trial. Clinical trials test the effectiveness of an
investigational imaging technique to learn whether the investigational imaging technique
works in 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 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, the investigators hope that they can better detect changes in the
heart muscle before and after treatment with doxorubicin with the CMR scan in hopes that
cardiac injury can be detected and treated earlier to prevent heart failure.
investigational imaging technique to learn whether the investigational imaging technique
works in 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 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, the investigators hope that they can better detect changes in the
heart muscle before and after treatment with doxorubicin with the CMR scan in hopes that
cardiac injury can be detected and treated earlier to prevent heart failure.
If you decide to participate in this research study, you will be asked to undergo some
screening procedures to determine if you are eligible. These procedures include: medical
history, determination of kidney function and a pregnancy test (if applicable). The
investigators will also ask you to sign a CMR safety screening form that makes sure it is
safe for you to have the CMR scan. If you have metallic implants (pacemakers,
defibrillators, or aneurysm clips) or metallic fragments in your eye, you should not have a
CMR. If these tests show that you are eligible to participate in the research study, you
will begin the study. If you do not meet the eligibility criteria, you will not be able to
participate in this research study.
Visit 1 will take place prior to starting doxorubicin chemotherapy. The visit will take
about 1.5 hours. The investigators will ask you to come to the Shapiro Cardiovascular Center
at the Brigham and Women's Hospital for your study visit. For subjects that qualify, the
investigators will bring you to the basement level of the hospital for the heart CMR scan,
an echocardiogram and some blood work. Before your CMR scan the investigators will take some
blood via the IV cannula. The investigators will take about 4 tubes of blood. This is
equivalent to 2.5 tablespoons of blood. From this blood the investigators will test for
blood markers of cardiac injury and compare these results to your other tests.
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. The investigators 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. The investigators 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, the investigators may prescribe a drug to help you
relax you if you think it might be helpful. The CMR scan will take one hour.
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 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.
At Visit 3 the investigators 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. The
investigators 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 the investigators will measure oxygen levels.
It will take you 12-16 months to complete this research study, depending on the date and
timing of your chemotherapy. During this time, the investigators will ask you to make 3
study visits. The investigators will call you after approximately six months to see how you
are doing.
screening procedures to determine if you are eligible. These procedures include: medical
history, determination of kidney function and a pregnancy test (if applicable). The
investigators will also ask you to sign a CMR safety screening form that makes sure it is
safe for you to have the CMR scan. If you have metallic implants (pacemakers,
defibrillators, or aneurysm clips) or metallic fragments in your eye, you should not have a
CMR. If these tests show that you are eligible to participate in the research study, you
will begin the study. If you do not meet the eligibility criteria, you will not be able to
participate in this research study.
Visit 1 will take place prior to starting doxorubicin chemotherapy. The visit will take
about 1.5 hours. The investigators will ask you to come to the Shapiro Cardiovascular Center
at the Brigham and Women's Hospital for your study visit. For subjects that qualify, the
investigators will bring you to the basement level of the hospital for the heart CMR scan,
an echocardiogram and some blood work. Before your CMR scan the investigators will take some
blood via the IV cannula. The investigators will take about 4 tubes of blood. This is
equivalent to 2.5 tablespoons of blood. From this blood the investigators will test for
blood markers of cardiac injury and compare these results to your other tests.
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. The investigators 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. The investigators 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, the investigators may prescribe a drug to help you
relax you if you think it might be helpful. The CMR scan will take one hour.
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 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.
At Visit 3 the investigators 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. The
investigators 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 the investigators will measure oxygen levels.
It will take you 12-16 months to complete this research study, depending on the date and
timing of your chemotherapy. During this time, the investigators will ask you to make 3
study visits. The investigators will call you after approximately six months to see how you
are doing.
Inclusion Criteria:
- New diagnosis of lymphoma
- Scheduled to undergo doxorubicin-based chemotherapy
Exclusion Criteria:
- Concurrent radiotherapy prior to the performance of both CMR studies
- Prior malignancy treated with chemotherapy or mediastinal radiotherapy
- Contraindications to performance of a magnetic resonance study: presence of implanted
metallic object, implanted neural stimulator, ferromagnetic implants not deemed MRI
safe, intra-ocular metallic foreign bodies, severe claustrophobia, pregnancy,
inability to perform exercise test
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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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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