Radiation-related heart damage in locally advanced NSCLC tested with PET-CT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective phase 2 study examines the heart after chemoradiation in locally advanced NSCLC, using 18F-Flurpiridaz PET-CT to measure blood flow and reserve before and after therapy. It also includes coronary CT angiography to assess coronary anatomy. The goal is to see if imaging can identify early cardiotoxic changes and aid in protecting the left anterior descending artery during treatment. Eligible participants are adults with stage III NSCLC planned for definitive concurrent chemoradiation near the heart, with prior health assessments to ensure safe imaging. The study is conducted at Indiana University and aims to correlate imaging findings with treatment parameters.

Why it matters

Who can join: the full rules

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.

Where it's running

• Indiana University Melvin and Bren Simon Comprehensive Cancer Center
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Jordan Holmes, MD — Indiana University
• Study coordinator: Jessica Anders
• Email: jemlynn@iu.edu
• Phone: 1 317-278-2722

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.