Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

Study Overview
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Brief Summary
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This is a prospective observational study aiming: 1) To quantify lung function using perfusion dual energy computed tomography (DECT) and use this information at the time of treatment planning with preferential sparing of functional lung parenchymal 2) to validate results of lung function obtained using DECT with lung perfusion scintigraphy results, the current standard method; 4) to compare dosimetry of whole lungs vs. functional lungs in patients treated with either stereotactic body radiotherapy (SBRT) for early stage lung cancer or conventional radiotherapy for locally advanced lung cancer and 5) to evaluate lung function 6, 12 and 24 months post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.

Official Title
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PHASE I-II Study on the Use of Dual Energy Computed Tomography for Assessment of Lung Function in Thoracic Conventional and Stereotactic Body Radiotherapy

Conditions
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Lung Cancer, Lung Function Decreased, Radiation Pneumonitis

Intervention / Treatment
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* Radiation: Thoracic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years ECOG 0-2 Pulmonary neoplasia, confirmed histopathologically or by imaging Prognosis evaluated ≥ 1 year by attending MD Clinically acceptable lung capacity to undergo radiotherapy Initial assessment including history, physical examination, biochemistry, PFT, chest radiograph, chest and abdominal-pelvic scan, PET Written consent The patient must be available for treatment and monitoring. Patients registered in the study should be treated in our center. Exclusion criteria Previous radiotherapy in the radiation field Presence of any major medical condition that, in the opinion of the investigator, would prevent follow-up at 6, 12 and 24 months post-radiotherapy. Iodine allergy Pregnancy and lactation

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Thoracic radiotherapy|Patients will have pre-treatment and post-treatment perfusion DECT for baseline and post-treatment lung function|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function quantification at baseline | To quantify lung function using perfusion DECT and use this information at the time of treatment planning with preferential sparing of functional lung parenchyma. | Baseline | 
| Radiation-induced lung function damage quantification | To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map. | at 12 months after radiotherapy | 
| Radiation-induced lung function damage quantification | To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map. | at 24 months after radiotherapy |