CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy
Primary Purpose
Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CAPP-Seq
Isovue-200
Computed Tomography Perfusion Imaging
Sponsored by

About this trial
This is an interventional diagnostic trial for Malignant Lung Neoplasm
Eligibility Criteria
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
Sites / Locations
- Stanford University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (CT perfusion imaging)
Arm Description
Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent
Outcomes
Primary Outcome Measures
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning
Number of participants able to complete perfusion scan acquisition within 48 hours of SABR
Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR
Secondary Outcome Measures
The calculated variance of blood flow such that measurable changes can be identified in future studies
The calculated variance of blood volume such that measurable changes can be identified in future studies
The calculated variance of mean transit time such that measurable changes can be identified in future studies
The calculated variance of permeability such that measurable changes can be identified in future studies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02693080
Brief Title
CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy
Official Title
A Pilot Study of Perfusion CT for Lung Tumors Treated With Stereotactic Ablative Radiation Therapy (SABR)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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:
To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma, Stage IV Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (CT perfusion imaging)
Arm Type
Experimental
Arm Description
Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent
Intervention Type
Device
Intervention Name(s)
CAPP-Seq
Other Intervention Name(s)
Cancer Personalized Profiling by Deep Sequencing
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Isovue-200
Other Intervention Name(s)
Lopamidol
Intervention Description
Contrast agent
Intervention Type
Radiation
Intervention Name(s)
Computed Tomography Perfusion Imaging
Other Intervention Name(s)
CT Perfusion Imaging
Primary Outcome Measure Information:
Title
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning
Time Frame
Up to approximately 90 seconds
Title
Number of participants able to complete perfusion scan acquisition within 48 hours of SABR
Time Frame
Within 48 hours post-SABR
Title
Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR
Time Frame
Up to 4 months post-SABR
Secondary Outcome Measure Information:
Title
The calculated variance of blood flow such that measurable changes can be identified in future studies
Time Frame
Baseline to up to 4 months post-SABR
Title
The calculated variance of blood volume such that measurable changes can be identified in future studies
Time Frame
Baseline to up to 4 months post-SABR
Title
The calculated variance of mean transit time such that measurable changes can be identified in future studies
Time Frame
Baseline to up to 4 months post-SABR
Title
The calculated variance of permeability such that measurable changes can be identified in future studies
Time Frame
Baseline to up to 4 months post-SABR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maximilian Diehn
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy
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