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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET/CT scans to check for heart damage after standard chemotherapy and radiation. It is for adults with stage III non-small cell lung cancer who will get these treatments at the same time.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old when you agree to join.
  • You can give written consent and permission to use your health information.
  • You have stage III non-small cell lung cancer, confirmed by tissue testing and a PET/CT scan.
  • You will receive standard chemotherapy and radiation at the same time to treat the cancer.
  • Your doctor expects the tumor to be within 2 centimeters of your heart, or your heart’s average radiation dose to be more than 10 Gy (a unit of radiation).

Who can't join

  • For the study: You have had radiation to the chest before, or you are being treated with SBRT, a type of highly focused radiation.
  • For the heart artery CT scan (CCTA): You have had a severe allergic reaction called anaphylaxis to iodine-based contrast dye.
  • For CCTA: You have poor kidney function, with an estimated creatinine clearance below 30 mL/min.
  • For CCTA: You cannot hold your breath for more than 5 seconds.
  • For CCTA: You are receiving radioactive iodine treatment.
  • For the flurpiridaz PET/CT test: You have certain heart rhythm problems without a working pacemaker. These include second- or third-degree heart block or problems with the heart’s natural pacemaker.
  • For the PET/CT test: You have an airway disease, such as asthma or COPD, with a flare-up or active wheezing on the scan day.
  • For the PET/CT test: Your top blood pressure number is below 90 on the scan day.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

IN