Actively Recruiting
The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR
Led by Odense University Hospital · Updated on 2023-12-06
100
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of radiotherapy on the heart in patients with loco-regional advanced non-small cell lung cancer (NSCLC) who are planned for curative treatment with chemoradiotherapy. The study aims to understand both early and late heart toxicity caused by this treatment and to assess the baseline heart health of these patients. It focuses on heart function and potential heart disease using ECG and cardiac magnetic resonance imaging (MRI). Patients will be followed in two study groups: one group will have cardiac MRI and ECG tests before starting treatment and again at 6, 12, and 24 months after radiotherapy. The second group will have one cardiac MRI and ECG test between 12 and 24 months after treatment if not included in the first group. All patients receive radiotherapy alone or combined with chemotherapy with curative intent. Participants will undergo heart function assessments using ECG and cardiac MRI at specified intervals to detect structural changes and subclinical heart disease after radiotherapy. Researchers will monitor overall survival, heart function changes, treatment-related adverse events, and cardiovascular mortality over two years. The study involves regular imaging and clinical evaluations to understand the heart's response to treatment and ensure patient safety during follow-up.
CONDITIONS
Brief Title
COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of inoperable and histologically or cytologically confirmed non-small cell lung cancer
- Planned treatment with curative intent using radiotherapy or chemoradiotherapy
- Ability to complete study procedures including ECG and cardiac MRI
- Ability to provide written informed consent before starting study procedures
You will not qualify if you...
- Vulnerable patients
- Patients with implanted devices such as pacemaker, ICD, or cochlear implant that contraindicate MRI
- Claustrophobia preventing MRI examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and baseline evaluations including history, ECG, and cardiac MR
Duration - Up to 2 years after radiotherapy
Participants undergo cardiac assessments with ECG and cardiac Magnetic Resonance scans before and after radiotherapy to evaluate heart function and detect possible heart disease caused by treatment.
Cardiac MR and ECG at baseline, and at 6, 12, and 24 months after radiotherapy; some participants have 1 cardiac MR and ECG between 12-24 months depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense C, Denmark, 5000
Actively Recruiting
Research Team
A
Agon AO Olloni, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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