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| ID | Type | Description | Link |
|---|---|---|---|
| HM20000190 | Other Identifier | VCU IRB | |
| MCC20000190 | Other Identifier | VCU Massey Cancer Center | |
| NCI-2014-00113 | Registry Identifier | NCI CTRP |
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slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.
PRIMARY OBJECTIVES:
I. Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).
II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.
OUTLINE:
Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) | Experimental | Patients undergo 15 imaging studies: 5 chest CT scans, 5 chest MRI scans, 5 PET scans. Each scan will be obtained before treatment begins, weeks 2 and 4 during radiation therapy, 3 months and 1 year following radiation therapy. THe chest CT obtained pre-treatment, at 3 months post treatment and 1 year post treatment are considered routine and would be obtained regardless of study participation. The pre-treatment PET scan is also considered routine. All other scans are being done for the purposes of this research. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diffusion-weighted magnetic resonance imaging | Device | Undergo diffusion-weighted MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of gross tumor volume and involved lymph nodes | A paired sample t-test could be applied to test the difference between MRI, CT, and PET-CT contours. Parameters used for comparison will include volume size, volume overlap, such as Dice similarity coefficients and Jaccard index, and surface distance maps including Hausdorff distance. | Up to 3 months |
| Change in functional response | Patients will be classified into responders and non-responders based on their PET signal which will serve as the reference method for response assessment. Although this is a little different from the three group analysis of variance (ANOVA) used in the power calculation, it is expected that there will be similar high power when the partial responders and non-responders are combined. Receiver operating characteristic (ROC) analysis will be used to define a threshold of apparent diffusion coefficient (ADC) change to stratify between metabolic responders vs. non-responders. | Baseline to 3 months |
| Spatial concordance of multimodality imaging for whole image registration | A paired sample t-test will be used. | Up to 3 months |
| Temporospatial registrations of radioresistant sub-volumes | A paired sample t-test will be used. ROC analysis will be performed only for radioresistant sub-volumes to identify which diffusion weighted-MRI functional signal thresholds correlate with levels of tumor activity defined on PET. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ADC | Fourth week ADC change will be compared to metabolic response defined by the fourth week PET using three group ANOVA and ROC analysis. | Baseline to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Weiss, MD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298 | United States |
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| 4-dimensional computed tomography | Device | Undergo 4D CT |
|
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| fludeoxyglucose F 18 | Radiation | Undergo FDG-PET |
|
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| FDG-PET | Device | Undergo FDG-PET |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D038524 | Diffusion Magnetic Resonance Imaging |
| D056973 | Four-Dimensional Computed Tomography |
| D019788 | Fluorodeoxyglucose F18 |
| D049268 | Positron-Emission Tomography |
| D014054 | Tomography |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D021621 | Imaging, Three-Dimensional |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D014055 | Tomography, Emission-Computed |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
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