Study Stopped
Funding
Cardiac Fibrosis by CMR in Patients With Cancer
Non-invasive Detection of Cardiac Fibrosis After Administration of Doxorubicin-based Chemotherapy in Patients With Lymphoma Using Cardiac Magnetic Resonance
1 other identifier
observational
N/A
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2018
CompletedSeptember 14, 2018
September 1, 2018
5.5 years
July 11, 2013
September 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial ECV
\- 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.
2 Years
Secondary Outcomes (4)
Alteration of serum biomarkers after doxorubicin based chemotherapy
2 years
Alteration of echocardiographic indices after doxorubicin-based chemotherapy
2 Years
Measurement of cardiopulmonary functional capacity
2 years
Determine association between measurements pre- and post-doxorubicin-based chemotherapy
2 Years
Study Arms (1)
Cardiac Magnetic Resonance
Cardiac Magnetic Resonance scan at visits 1 and 2
Interventions
Eligibility Criteria
Patients receiving chemotherapy
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Insitute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tomas Neilan, MD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 24, 2013
Study Start
March 1, 2013
Primary Completion
August 25, 2018
Study Completion
August 25, 2018
Last Updated
September 14, 2018
Record last verified: 2018-09