Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2012-07-31
2014-08-31
Brief Summary
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Detailed Description
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By using 4D CT scans, researchers can create images that show how air moves through the lungs. This new method to check lung function may make better images than the standard methods. Researchers will compare 4 images of how air moves through your lungs and 1 image while you hold your breath.
Study Groups:
If you are found to be eligible to take part in this study (if the screening test is applicable) and you agree to take part in this study, you will be enrolled in 1 of 2 study groups, depending on when you join the study. There will be up to 18 participants in each group. In the first group, researchers will test several different methods to create images of how air moves through the lungs. Researchers will then select the most successful methods from the first group and try to do them again with the second group.
Study Visits:
You will have up to two visits for this study. At these visits, you will have four 4DCT scans performed (for Group 1) or five scans (for Group 2) using both the 4DCT and spiral CT, while you are breathing normally. You will also have 1 scan while you hold your breath for less than 20 seconds. The CT scans will take about 5 minutes each to complete. If the spiral CT scans for Group 2 cannot be completed on the same day as the 4DCT scans, you will be asked for your willingness to return at a later day to complete these.
The 4D CT scan will cover the entire chest area using the standard dose of radiation. A 2-inch plastic box will be placed on top of your chest to track the motion of your chest while you breathe during each scan. Some parts of your chest will be scanned up to 2 more times based on your breathing.
The entire scanning session will take about 45 minutes to complete.
Length of Participation:
Your active participation on the study will be over when you have completed your study visit.
Follow-Up Phone Call:
Within 7 days after your last study visit, the study staff will call you to ask about any side effects you may be having. This call should last about 2 minutes.
If anything unusual is found in the imaging, your cancer doctor will be told so that you can receive follow-up.
This is an investigational study. The CT scans used in this study are delivered using FDA-approved and commercially available systems. Creating images of how air moves through the lungs from 4D CT scans is considered investigational.
Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1
Cohort of 18 subjects evaluated. Subject will receive 4DCT cine acquisition gated using a respiratory signal from real-time position management (RPM) gating system. Maximum number of allowable images that may be acquired increased from 3000 to 5999 images. Total imaging time for each subject \< 60 minutes.
4D CT scans
4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.
Cohort 2
Reproducibility of optimal 4DCT acquisition method determined from cohort 1 tested with cohort of 18 study subjects. Three 4DCT images acquired, all with acquisition method determined from cohort 1. Cohort also receives two spiral-mode 4DCT acquisitions.
4D CT scans
4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.
Interventions
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4D CT scans
4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with pathologic diagnosis of esophagus or lung cancer.
3. Patient who plan to receive radiation therapy treatment at MD Anderson.
4. Patient \>/=18 years of age
Exclusion Criteria
2. Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Thomas Guerrero, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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1dp20D007044-01
Identifier Type: OTHER
Identifier Source: secondary_id
2011-0631
Identifier Type: -
Identifier Source: org_study_id