A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer

Study Overview
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Brief Summary
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Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment Primary objectives: To assess pre-treatment global and focal lung strain and correlate with changes post-treatment

Detailed Description
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The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using four dimensional CT (4D-CT) treatment planning scans. Patients with newly diagnosed lung cancer will be planned using 4D-CT to assess lung and tumor motion. Standard radiation treatment plans will to delivered based on tumor stage. Patients will be reassessed both clinically and radiographically using 4D-CT imaging at 3 months and 6 months post-treatment. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

Official Title
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A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: 4D-CT pre-treatment scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 years ECOG performance status 0-1 Pathologic or clinical diagnosis of lung malignancy Patients must have a reproducible tidal volume sufficient for 4D-CT imaging Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging. Pregnant women or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>Single Arm | Radiation: 4D-CT pre-treatment scan<br>* Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment<br>* Other names: 4D-CT study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes. | The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans. | Pre-treatment (baseline) up to 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans. | 4D-CT based lung strain modeling comparison with standard lung function | 2 years post treatment | 
| correlate pre- and post-treatment strain with clinical toxicity | Toxicity correlation | Pre-treatment (baseline) to 2 years post treatment | 
| correlate post-treatment strain with radiographic changes to the lung parenchyma | Lung parenchyma correlation | 2 years post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer