Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma, Stage IV Lung Cancer
Conditions
Brief summary
This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.
Detailed description
PRIMARY OBJECTIVES: I. To assess the feasibility of performing computed tomography (CT) perfusion imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care. SECONDARY OBJECTIVES: 1. To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR 2. To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR 3. To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR 4. To correlate perfusion parameters with tumor response 1 year post-SABR OUTLINE: Patients receive an infusion of Isovue-200 and undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) will be conducted evaluate circulating-tumor DNA levels. Perfusion parameters will be correlated with tumor control at 1 year post-SABR, with tumor control defined as no evidence of disease seen at the site of SABR by surveillance imaging at 1 year post-SABR. After completion of treatment, patients are followed up at 2-4 months and then at 1 year.
Interventions
DEVICECAPP-Seq
Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) is an assay which allows quantitative assessment of the levels of circulating-tumor DNA in the blood sample.
DRUGIsovue-200
Contrast agent
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
Exclusion criteria
* Patients who are pregnant or are trying to become pregnant are excluded from this study * Patients with renal failure, defined as glomerular filtration rate (GFR) \< 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants able to complete perfusion scan acquisition at the time of treatment-planning | Up to approximately 90 seconds |
| Number of participants able to complete perfusion scan acquisition within 48 hours of SABR | Within 48 hours post-SABR |
| Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR | Up to 4 months post-SABR |
Secondary
| Measure | Time frame |
|---|---|
| The calculated variance of blood flow such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
| The calculated variance of permeability such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
| The calculated variance of blood volume such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
| The calculated variance of mean transit time such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
Countries
United States
Outcome results
None listed