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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Single Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4D-CT pre-treatment scan | Radiation | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal E Dunlap, MD | James Graham Brown Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |