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This is a prospective study of ventilation image comparison for lung functional information incorporation in thoracic cancer treatment planning.
Investigators hypothesize that a high resolution regional ventilation image (HRVI) based on 4D-CT imaging will correlate with the current low resolution state-of-the-art (SPECT-CT), which is the conventional way of measuring ventilation. HRVI may be a tool that could be widely used throughout the radiation therapy community because most radiation oncologists routinely employ 4D-CT technology in their own clinics. Investigators plan to test this hypothesis by comparing ventilation patterns on SPECT-CT images to HRVIs using a DICE analysis. As SPECT ventilation imaging is not included in our standard care, this study thus is designed as a pilot study.
Based on published data, the difference between the two methods for calculating the regional ventilation in the lower 50% ventilation volume is expected to have a standard deviation of about 0.1. Therefore, the 95% confidence interval for the difference in the regional ventilation between SPECT-CT and 4D-CT pre-treatment would have a width of no more than 0.14 if 10 patients are enrolled and as small as 0.10 when 20 patients are registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventilation Images for Comparison | Other | Standard of Care: 4-D CT scan will be used to make a radiation treatment plan. SPECT-CT Scan: This second scan will be done on another day to make a treatment plan for comparison to the first plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-D CT Scan | Diagnostic Test | The 4-D CT scan shows how the tumor moves when patients breathe so that motion can be taken into account when planning the radiation. This is the usual way of planning lung radiation and everyone in this study will be planned using a 4-D CT scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Correlation of Ventilation Images | The primary objective is to compare the regional ventilation using SPECT-CT and that as determined from the pre-treatment 4D-CT routinely collected at simulation in lung/abdominal patients (standard of care). 50% of the lower portion lung image will be used for the purpose of determining the regional ventilation for this protocol. | Up to 1 year |
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Inclusion Criteria:
Patients that have early stage non-small cell lung cancer or clinical suspicion of the same in cases where the lesion is not amenable to biopsy but is enlarging and PET-positive. All patients are to be treated with stereotactic body radiation therapy as a monotherapy.
Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC 7th edition stage I or II based on only one of the following combinations of TNM staging:
Must be at least 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Women of childbearing potential and male participants must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Dilling, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| D015899 | Tomography, Emission-Computed, Single-Photon |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| SPECT-CT Scan | Diagnostic Test | It may be possible to make a more accurate plan by using a SPECT-CT scan for planning that would result in less damage to healthy lung tissue. This is not yet proven. A SPECT-CT scan uses a special camera to detect radioactivity to produce pictures which can lead to more precise information. |
|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |