Imaging Study Compare 4DCT Image

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01626001
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : November 18, 2015
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn about ways to possibly reduce scanning errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in patients with esophageal or lung cancer.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Lung Cancer Procedure: 4D CT scans Phase 1

Detailed Description:

Study Procedure:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Imaging Study to Compare Methods to Reduce 4DCT Image Acquisition Artifacts
Study Start Date : July 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Procedure: 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 Names:
  • CT
  • X-ray
  • Computed Tomography

Experimental: 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.
Procedure: 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 Names:
  • CT
  • X-ray
  • Computed Tomography

Primary Outcome Measures :
  1. Patient Percentage with 4DCT Acquisition Artifacts [ Time Frame: 1 day ]
    Primary statistical analysis is intra-subject comparison of artifacts versus acquisition methods. In cohort 1: 4DCT acquisition techniques consist of 1) baseline acquisition, 2) extended acquisition, 3) real-time acquisition gating, and 4) re-imaging of bad segments. An automated computer scoring system, as described by Han et al., will be implemented and validated using the first 5 cases. To quantify 4DCT image quality, number and anatomic misplacement distance of artifacts will be measured, for each set of acquisition methods and each subject.

Secondary Outcome Measures :
  1. Artifact Reproducibility Reducing 4DCT Acquisition [ Time Frame: 1 day ]
    Winning acquisition method with lowest average misplacement per subject selected for evaluation of reproducibility. Goal is to quantify intra-subject variance for selected winning 4DCT acquisition method on image parameters significant for calculation of 4DCT ventilation images. Both acquisition artifacts and physiological parameters (global average HU, ΔHU, the tidal volumes, and the lung mass) assessed for reproducibility with evaluation of mean and variance.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Patients must sign consent for the study.
  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:

  1. Presence of an implanted electronic device.
  2. Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant.

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 identifier (NCT number): NCT01626001

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Principal Investigator: Thomas Guerrero, MD,PHD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01626001     History of Changes
Other Study ID Numbers: 2011-0631
1dp20D007044-01 ( Other Identifier: NIH Director's New Innovator Award )
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: August 2014

Keywords provided by M.D. Anderson Cancer Center:
Esophagus Cancer
Lung Cancer
4-dimensional computed tomography

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases