Recruiting
Phase 2

Chemotherapy & Radiation

Sponsor:

Indiana University

Code:

NCT07761910

Conditions

Non Small Cell Lung Cancer

Cardiotoxicity

Locally Advanced Non-Small Cell Lung Cancer

Radiation Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET/CT 18F-Flurpiridaz Rest/Stress Test

Coronary CT Angiography (CCTA)

18F-Flurpiridaz

Study Details

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

Study ID

NCT07761910

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Coronary CT Angiography (CCTA)

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

18F-Flurpiridaz

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

Primary outcome measure

  • Change of MBF (myocardial blood flow) [ Time Frame: Pre-radiotherapy and 3 months post-radiotherapy ]

Central Contacts and Locations

Central contacts

Locations

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Jordan Holmes, MD

More Information

Sponsor

Indiana University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-12.