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

NCT07761910 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: CTO-IUSCCC-0896
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Small Cell Lung Cancer; Cardiotoxicity; Locally Advanced Non-Small Cell Lung Cancer; Radiation Therapy

Keywords

PET-CT; Radiation Injury; locally advanced Non-Small Cell Lung Cancer; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Change of MBF (myocardial blood flow)

  Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT

  Pre-radiotherapy and 3 months post-radiotherapy

Secondary Outcomes (4)

• 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

Study Arms (1)

PET/CT 18F-Flurpiridaz Rest/Stress Test

EXPERIMENTAL

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

Interventions

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.

PET/CT 18F-Flurpiridaz Rest/Stress Test

Coronary CT Angiography (CCTA) DEVICE

Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.

PET/CT 18F-Flurpiridaz Rest/Stress Test

18F-Flurpiridaz DRUG

A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment

PET/CT 18F-Flurpiridaz Rest/Stress Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients treated with stereotactic body radiotherapy (SBRT).
• Prior thoracic radiotherapy.
• 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.
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Cardiotoxicity; Radiation Injuries

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Jordan Holmes, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Anders

CONTACT

1 317-278-2722; jemlynn@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology Oncology

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

US (1)