NCT07761910 · Indiana University
Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
What this study is about
forward-looking clinical study designed to evaluate damage to the heart after receiving the usual treatment chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).
View original scientific description
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).
Interventions
DIAGNOSTIC_TEST
PET/CT 18F-Flurpiridaz Rest/Stress Test
A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment.
DEVICE
Coronary CT Angiography (CCTA)
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
DRUG
18F-Flurpiridaz
A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment
Primary outcome measures
Change of MBF (myocardial blood flow)
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Indianapolis, Indiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations