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NCT02496260 · ClinicalTrials.gov registry record
Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy
A clinical trial, sponsored by Henry Ford Health System.
- Completed
- Registry status
- 25
- Enrollment target
NCT02496260: Completed study, sponsored by Henry Ford Health System.
NCT02496260 is a clinical trial that has completed, run by Henry Ford Health System. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02496260 has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- PROCEDURE Research Cardiac MRI
- PROCEDURE Biomarkers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-12 |
What the finished NCT02496260 record still lists
NCT02496260 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Research Cardiac MRI is the first listed.
NCT02496260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02496260 about?
NCT02496260 is a clinical study titled "Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy". 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, ...
What is the current status of trial NCT02496260?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2015-07. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02496260?
The interventions under investigation include: Research Cardiac MRI (PROCEDURE), Biomarkers (PROCEDURE).
Who is sponsoring clinical trial NCT02496260?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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