Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02494453 · ClinicalTrials.gov registry record
Pilot Study of Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy
A clinical trial, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- 23
- Enrollment target
NCT02494453: Completed study, sponsored by University of Michigan Rogel Cancer Center.
NCT02494453 is a clinical trial that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02494453 has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- 23 participants
- Enrollment target
Study Summary
Patients with breast cancer receive low 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 wish to 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 radiotherapy (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 | 23 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-07 |
What the finished NCT02494453 record still lists
NCT02494453 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 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.
NCT02494453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02494453 about?
NCT02494453 is a clinical study titled "Pilot Study of Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy". Patients with breast cancer receive low 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, ...
What is the current status of trial NCT02494453?
This trial is currently completed. The enrollment target is 23 participants. The study started on 2015-06. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02494453?
The interventions under investigation include: Research Cardiac MRI (PROCEDURE), Biomarkers (PROCEDURE).
Who is sponsoring clinical trial NCT02494453?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia