Lung Cancer
Conditions
Keywords
lung cancer
Brief summary
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
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.
Interventions
RADIATION4D-CT pre-treatment scan
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
Sponsors
James Graham Brown Cancer Center
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes. | Pre-treatment (baseline) up to 6 months post-treatment | The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans. | 2 years post treatment | 4D-CT based lung strain modeling comparison with standard lung function |
| correlate pre- and post-treatment strain with clinical toxicity | Pre-treatment (baseline) to 2 years post treatment | Toxicity correlation |
| correlate post-treatment strain with radiographic changes to the lung parenchyma | 2 years post-treatment | Lung parenchyma correlation |
Countries
United States
Outcome results
None listed