- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496260
Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy
February 17, 2022 updated by: Dr. Eleanor Walker, Henry Ford Health System
Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure
Radiotherapy plays an integral role in breast cancer therapy.
Multiple randomized studies have demonstrated decreased local-regional recurrence rates and decreased breast-cancer mortality.
However, balanced with this survival benefit is the potential toxicity of the treatment itself.
In particular, cardiac effects of radiotherapy have been a concern and an area of research for the past 20 years.
From long-term follow up of patients with lymphoma, it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular dysfunction, systolic and diastolic function abnormalities, and heart failure among cancer-survivors.
Patients with breast cancer receive lower doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy.
Indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold.
This study aims to develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects, so they can be targeted for close monitoring and early intervention, potentially with statins or ACE inhibitors.
Additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to RT field design for patients sensitive to RT effects.
Finally, this information can be incorporated into better designs of treatment plans for future patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Radiotherapy plays an integral role in breast cancer therapy.
Multiple randomized studies have demonstrated decreased local-regional recurrence rates and decreased breast-cancer mortality.
However, balanced with this survival benefit is the potential toxicity of the treatment itself.
In particular, cardiac effects of radiotherapy have been a concern and an area of research for the past 20 years.
From long-term follow up of patients with lymphoma, it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular dysfunction, systolic and diastolic function abnormalities, and heart failure among cancer-survivors.
Patients with breast cancer receive lower doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy.
Indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold.
The investigators hypothesize that they can develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects.
These patients can then be targeted for close monitoring and early intervention, potentially with statins or ACE inhibitors.
Additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to RT field design for patients sensitive to RT effects.
Finally, this information can be incorporated into better designs of treatment plans for future patients.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
This is a pilot study of patients receiving radiotherapy for left-sided breast cancer.
Description
Inclusion Criteria:
- Patients who will receive RT for left-sided breast cancer and can have a contrast-enhanced MRI are eligible.
Exclusion Criteria:
- Patients who have a contraindication to contrast-enhanced MRI are not eligible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients in which cardiac MRI indicated subclinical cardiac abnormalities after radiotherapy that correlated with cardiac events
Time Frame: One year
|
The study aims to characterize longitudinal changes in imaging characteristics of cardiac damage.
Cardiac MRI endpoints will include myocardial edema, microvascular dysfunction, myocardial fibrosis, and subclinical impairment of systolic and diastolic function.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number patients in which blood and serum biomarkers were identified that correlated with cardiac damage due to radiation
Time Frame: One year
|
The study aims to characterize longitudinal changes in potential early biomarkers of cardiac damage.
Biomarker endpoints derived from blood or its components include measuring levels of galectin-3, NT-Pro brain natriuretic peptide, troponin, C-reactive protein, myeloperoxidase, and growth differentiation factor 15.
|
One year
|
Number of unique biomarkers identified that were associated with radiation related cardiac injury
Time Frame: One year
|
Biomarker endpoints derived from blood or its components include measuring levels of galectin-3, NT-Pro brain natriuretic peptide, troponin, C-reactive protein, myeloperoxidase, and growth differentiation factor 15. Additional biomarkers may be included as the research in those fields progresses during the conduct of this clinical trial.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
June 23, 2015
First Submitted That Met QC Criteria
July 9, 2015
First Posted (Estimate)
July 14, 2015
Study Record Updates
Last Update Posted (Actual)
March 3, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9481
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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