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NCT Number: NCT07761910

Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Jessica Anders

CONTACT

[email protected]

317-278-2722

Jordan Holmes, MD

PRINCIPAL_INVESTIGATOR

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Anders

CONTACT

[email protected]

1 317-278-2722

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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