Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer · Cardiotoxicity · Locally Advanced Non-Small Cell Lung Cancer · Radiation Therapy
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 10 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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).
Read the full description
As the survival for NSCLC has gradually improved, there is increasing concern about long term radiation-induced cardiac toxicities and support in minimizing the dose to the left anterior descending artery. Myocardial perfusion (the delivery of blood to the heart muscle) evaluated by PET CT scans could be a useful tool to assess early cardiac damage by radiation, so this study will prospectively and quantitatively assess myocardial blood flow and myocardial flow reserve with 18F-Flurpiridaz PET CT prior to and after radiation therapy.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
1. Age ≥ 18 at time of consent
2. Ability to provide written informed consent and HIPAA authorization
3. Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.
4. To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.
5. Tumor estimated to be within 2cm of heart contour or anticipated MHD\>10Gy per treating physician.
Exclusion Criteria:
1. Patients treated with stereotactic body radiotherapy (SBRT).
2. Prior thoracic radiotherapy.
Exclusion for Coronary computed tomography angiography (CCTA)
1. History of a severe anaphylactic reaction to iodinated contrast.
2. Renal insufficiency (defined as estimated CrCl less than 30 mL/min).
3. Inability to hold breath for more than 5 seconds.
4. Patients on radioactive iodine therapy.
Exclusion for 18F-Flurpiridaz PET/CT Test
1. 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.
2. 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.
3. Patients who are hypotensive (systolic blood pressure less than 90 mm Hg) on the day of the PET/CT scan.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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.
Diagnostic Test: PET/CT 18F-Flurpiridaz Rest/Stress Test · Device: Coronary CT Angiography (CCTA) · Drug: 18F-Flurpiridaz
PET/CT 18F-Flurpiridaz Rest/Stress Test DIAGNOSTIC_TEST
A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment.
Coronary CT Angiography (CCTA) DEVICE
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
18F-Flurpiridaz DRUG
A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary 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
Secondary measures
Changes in myocardial blood flow to the cardiac base
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Changes in myocardial blood flow to the left ventricle
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Changes in myocardial blood flow to right coronary artery
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Changes in myocardial blood flow to left circumflex artery
Time frame: Pre-radiotherapy and 3 months post-radiotherapy
Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Indiana University
- Study start
- 2027-01 Estimated
- Primary completion
- 2027-07 Estimated
- Study completion
- 2027-10 Estimated
- First posted
- Aug 12, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
