Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Indiana University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change of MBF (myocardial blood flow)
Study Overview
Brief Summary
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: PET/CT 18F-Flurpiridaz Rest/Stress Test (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.
Intervention: 18F-Flurpiridaz (Drug)
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.
Intervention: Coronary CT Angiography (CCTA) (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Changes in myocardial blood flow to the cardiac base(Pre-radiotherapy and 3 months post-radiotherapy)
- Changes in myocardial blood flow to the left ventricle(Pre-radiotherapy and 3 months post-radiotherapy)
- Changes in myocardial blood flow to right coronary artery(Pre-radiotherapy and 3 months post-radiotherapy)
- Changes in myocardial blood flow to left circumflex artery(Pre-radiotherapy and 3 months post-radiotherapy)
Investigators
Jordan A Holmes,
Assistant Professor of Radiology Oncology
Indiana University