Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer
Investigating Heart Health in Lung Cancer Patients Undergoing a Combination of Chemotherapy and Radiation Therapy
Tim Lautenschlaeger
Primary Investigator
Brief description of study
Detailed description of study
This is a prospective clinical study designed to evaluate the impact of MHD and LAD dose on change of MBF (a two-phase, rest and regadenoson stress) evaluated by 13N-ammonia PET/CT before and 3 months after RT. The study will test the hypothesis that patients with lower LAD dose is associated with less MBF decrease induced by radiation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non-small cell lung cancer, NSCLC
-
Age: 18 years - 100 years
-
Gender: All
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 8 th edition guideline, confirmed by pathologically diagnosis and PET/CT
4. To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines CTO-IUSCCC-0896 Protocol Version Date: 11/21/2024 Page 8.
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. a history of a severe anaphylactic reaction to iodinated contrast precludes a repeat contrast administration.
2. Renal insufficiency (defined as CrCl less than 30 mL/min/1.73 m2)
3. Inability to hold breath for more than 5 seconds.
4. Patients on radioactive iodine therapy
5.4 Exclusion for 13N-ammonia PET/CT Test
1. With contraindications for regadenoson stress test including:
a) 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.
b) 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.
c) Patients who are hyposensitive (systolic blood pressure less than 90 mm Hg) on
the day of exam
This study investigates the effects of chemoradiation on heart health in patients with locally advanced Non-Small Cell Lung Cancer (NSCLC). The purpose of this study is to see if testing patients' hearts before and after treatment can help researchers understand how to reduce heart damage in the future. Non-Small Cell Lung Cancer is a type of lung cancer that is not small cell and is usually treated with a combination of chemotherapy and radiation therapy.
Participants will undergo a PET-CT scan, which is a type of imaging test that helps doctors see how the heart is working before and three months after radiation therapy. The study will compare heart imaging results to see if lower doses of radiation to a specific heart artery are linked to less heart damage. This involves two phases: resting and stress testing using a special medicine to see how the heart handles stress.
- Who can participate: Adults aged 18 and older with Stage III Non-Small Cell Lung Cancer, confirmed by pathology and PET/CT, who are receiving standard chemoradiation therapy are eligible. Participants should not have prior thoracic radiotherapy or be treated with stereotactic body radiotherapy.
- Study details: Participants will have PET-CT scans before and three months after radiation therapy. The scans will help researchers see how radiation affects the heart. A placebo is not used in this study.
Find a site
,
Send a message
Enter your contact details to connect with study team
Primary Contact
Interested in the study?
Select a study center that’s convenient for you, and get in touch with the study team.
Connect with the Study TeamPlease choose between Voice or SMS based delivery of verification code
or