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

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ClinicalTrials.gov Identifier: NCT03091816
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Society of Thoracic Radiology
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
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 Device: Computed Tomography Perfusion Imaging Other: Laboratory Biomarker Analysis Radiation: Stereotactic Body Radiation Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Perfusion Computed Tomography Changes After Stereotactic Body Radiation Therapy for Localized Non-small Cell Lung Cancer
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : May 8, 2020
Estimated Study Completion Date : May 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Computed Tomography Perfusion Imaging
Undergo DPCT

Other: Laboratory Biomarker Analysis
Correlative studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Name: SBRT




Primary Outcome Measures :
  1. Change in blood flow (mL/min/100 g) as measured on perfusion CT [ Time Frame: Baseline to up to 3 months post 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.

  2. Change in blood volume (mL/100 g) as measured on perfusion CT [ Time Frame: Baseline to up to 3 months post 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.

  3. Change in mean transit time (seconds) as measured on perfusion CT [ Time Frame: Baseline to up to 3 months post 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.

  4. Change in permeability (mL/min/100 g) as measured on perfusion CT [ Time Frame: Baseline to up to 3 months post 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.


Secondary Outcome Measures :
  1. Clinical tumor response assessed by CT scans as determined by Response Evaluation Criteria in Solid Tumors criteria version 1.1 [ Time Frame: Up to 24 months post SBRT ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091816


Contacts
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Contact: Rosaura Diaz 323-442-7469 Rosaura.diaz@med.usc.edu
Contact: Bhushan Desai 323-442-7469 Bhushan.Desai@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Rosaura Diaz    323-442-7469    Rosaura.diaz@med.usc.edu   
Contact: Bhushan Desai    323-442-7469    Bhushan.Desai@med.usc.edu   
Principal Investigator: Christopher Lee, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Society of Thoracic Radiology
Investigators
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Principal Investigator: Christopher Lee, MD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03091816     History of Changes
Other Study ID Numbers: 2N-16-1
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 )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases