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

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

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

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.

Inclusion Criteria:

1. Age >/= 18 years
2. ECOG performance status 0-1
3. Pathologic or clinical diagnosis of lung malignancy
4. Patients must have a reproducible tidal volume sufficient for 4D-CT imaging
5. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
6. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
7. Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

1. Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
2. Pregnant women or lactating women