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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01420 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2N-16-1 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Society of Thoracic Radiology | UNKNOWN |
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This pilot clinical trial studies the changes in dynamic perfusion computed tomography images before, during, and after stereotactic body radiation therapy in patients with stage I-II non-small cell lung cancer that has not spread to other parts of the body. Diagnostic imaging procedures, such as dynamic perfusion computed tomography, measure blood flow through tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving dynamic perfusion computed tomography images before, during, and after stereotactic body radiation therapy may help better understand how radiation therapy works to stop tumor growth in patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To describe perfusion computed tomography (CT) parameters and their changes in non-small cell lung cancer (NSCLC) tumors prior to, during, 1 month after, and 3 months after stereotactic body radiation therapy (SBRT).
SECONDARY OBJECTIVES:
I. To correlate tumor perfusion parameters with clinical tumor response on follow up per standard of care.
TERTIARY OBJECTIVES:
I. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cell (CTC) with clinical response rates and perfusion parameters.
OUTLINE:
Patients undergo dynamic perfusion computed tomography (DPCT) at baseline, during SBRT (after 2 of 3 fractions or 3 of 5 fractions), and then at 1 and 3 months post stereotactic body radiation therapy.
After completion of study, patients are followed up at 6, 12, 18, and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (DPCT) | Patients undergo DPCT at baseline, during SBRT (after 2 of 3 fractions or 3 of 5 fractions), and then at 1 and 3 months post stereotactic body radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography Perfusion Imaging | Device | Undergo DPCT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood flow (mL/min/100 g) as measured on perfusion CT | Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints. | Baseline to up to 3 months post SBRT |
| Change in blood volume (mL/100 g) as measured on perfusion CT | Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints. | Baseline to up to 3 months post SBRT |
| Change in mean transit time (seconds) as measured on perfusion CT | Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints. | Baseline to up to 3 months post SBRT |
| Change in permeability (mL/min/100 g) as measured on perfusion CT |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical tumor response assessed by CT scans as determined by Response Evaluation Criteria in Solid Tumors criteria version 1.1 | Descriptive statistics will also be used in the analyses of the secondary endpoints. Correlations between the endpoints will be examined with scatter plots and/or box plots. Patient's response status will be correlated with tumor perfusion parameters. | Up to 24 months post SBRT |
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Inclusion Criteria:
Biopsy proven non-small cell lung cancer
Minimum tumor dimension >= 1 cm (preferably >= 2 cm)
No clinical evidence of nodal disease (N1-N3) as assessed by CT and/or positron emission tomography (PET)/CT
Zubrod performance status 0-2
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
No prior radiation to the same area
No concurrent chemotherapy
Evaluated by radiation oncologist to be appropriate SBRT candidate and scheduled to undergo SBRT as part of their care
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
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Adult patients with lung cancer who will undergo SBRT at USC hospitals and clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Lee, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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Blood
| Laboratory Biomarker Analysis |
| Other |
Correlative studies |
|
| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
|
|
Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints. |
| Baseline to up to 3 months post SBRT |
| 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 |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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