Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Recruiting · NCT07761910 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
18F-FlurpiridazCoronary CT Angiography (CCTA)PET/CT 18F-Flurpiridaz Rest/Stress Test
What this trial is about
Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18 at time of consent
- Ability to provide written informed consent and HIPAA authorization
- Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.
- To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.
- Tumor estimated to be within 2cm of heart contour or anticipated MHD\>10Gy per treating physician.
Exclusion criteria
- Patients treated with stereotactic body radiotherapy (SBRT).
- Prior thoracic radiotherapy.
- Exclusion for Coronary computed tomography angiography (CCTA)
- History of a severe anaphylactic reaction to iodinated contrast.
- Renal insufficiency (defined as estimated CrCl less than 30 mL/min).
- Inability to hold breath for more than 5 seconds.
- Patients on radioactive iodine therapy.
- Exclusion for 18F-Flurpiridaz PET/CT Test
- Second-degree AV block, third-degree AV block, and sinus node disease (such as sick sinus syndrome or symptomatic bradycardia) without a functioning pacemaker.
- Note: Resting 12-lead EKG will be ordered at the time of enrollment to be performed prior to PET/CT stress test.
- Patients with bronchospastic diseases including asthma and chronic obstructive pulmonary disease (COPD) who have an acute exacerbation or active wheezing (a high-pitched, musical, adventitious lung sound produced by airflow through the narrowed airways) on the day of PET CT exam.
- Patients who are hypotensive (systolic blood pressure less than 90 mm Hg) on the day of the PET/CT scan.
Where it is running
1 location listed across 1 US state.
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis, Indiana, United States