Clinical trial · Observational
Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy
Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarkers | Procedure | — | UNRESOLVED |
| Research Cardiac MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients in which cardiac MRI indicated subclinical cardiac abnormalities after radiotherapy that correlated with cardiac events
- timeFrame
- One year
- description
- 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.
Secondary outcomes (2)
- measure
- Number patients in which blood and serum biomarkers were identified that correlated with cardiac damage due to radiation
- timeFrame
- One year
- description
- 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.
- measure
- Number of unique biomarkers identified that were associated with radiation related cardiac injury
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDMorris ED, Ghanem AI, Pantelic MV, Walker EM, Han X, Glide-Hurst CK. Cardiac Substructure Segmentation and Dosimetry Using a Novel Hybrid Magnetic Resonance and Computed Tomography Cardiac Atlas. Int J Radiat Oncol Biol Phys. 2019 Mar 15;103(4):985-993. doi: 10.1016/j.ijrobp.2018.11.025. Epub 2018 Nov 22. PMID 30468849