NCT03091816

Dynamic Perfusion Computed Tomography in Patients With Localized Non-small Cell Lung Cancer

Dynamic Perfusion Computed Tomography Changes After Stereotactic Body Radiation Therapy for Localized Non-small Cell Lung Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stage IA Non-Small Cell Lung Carcinoma
• Stage IB Non-Small Cell Lung Carcinoma
• Stage IIA Non-Small Cell Lung Carcinoma
• Stage IIB Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DEVICE	Computed Tomography Perfusion Imaging	Undergo DPCT
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2017-05-08
• Primary completion: 2023-03-02
• Completion: 2024-03-07
• First posted: 2017-03-27
• Last updated: 2024-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study