Cardiac Fibrosis by CMR in Patients With Cancer

Withdrawn before enrolling

Conditions studied: Lymphoma

In brief

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

Key facts

Study ID

NCT01906437

Run by

Massachusetts General Hospital

People needed

0

Starts

2013-03-01

Expected to finish

2018-08-25

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 and able to give consent
• New diagnosis of lymphoma and scheduled to undergo doxorubicin (DOX)-based chemotherapy.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Insitute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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