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

NCT ID: NCT03091816

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2024-03-07

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Computed Tomography Perfusion Imaging

Intervention Type: DEVICE

Undergo DPCT

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Undergo SBRT

Interventions

Computed Tomography Perfusion Imaging

Undergo DPCT

Intervention Type: DEVICE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type: RADIATION

Other Intervention Names

SBRT

Eligibility Criteria

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:

• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• 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

• Patients with tumors < 1 cm
• Patients with nodal disease or distant metastatic disease
• Patients may not be receiving any other investigational agents
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not be pregnant
• Patients with allergies to iodinated contrast not amenable to pre-medication
• Patients who are not able to lie supine with arms raised, and cooperate with breathholding instructions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Society of Thoracic Radiology

UNKNOWN

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2016-01420

Identifier Type: REGISTRY

Identifier Source: secondary_id

2N-16-1

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2N-16-1

Identifier Type: -

Identifier Source: org_study_id