4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies

October 23, 2018 updated by: M.D. Anderson Cancer Center

Phase II Trial Comparing 4-Dimensional Computed Tomography Derived Ventilation Versus SPECT/CT Tc-99m Aerosol Ventilation in Patients With Thoracic Malignancies

Objectives:

Primary Objective:

1. To determine the correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation.

Secondary Objective:

  1. To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting.
  2. To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies.
  3. To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

By using a 4-dimensional (4D) computed tomography (CT) scans researchers will create ventilation (circulation of air) calculations. This new calculation method is quicker and may produce better images than the standard ventilation calculations.

If you agree to take part in this study and are found to be eligible, you will have lung function imaging. Lung function imaging gives researchers information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.

You will have three 4D CT scans performed while you are breathing quietly. A 2-inch plastic box will be placed on top of your chest to monitor the motion of your chest during the scanning. After you are out of the CT scanner (once the scanning is finished), ventilation images are calculated from the 4D CT images and will be compared with the standard ventilation imaging method. The 4D CT imaging will take about 30 minutes to complete.

As part of standard care, once you have finished the 4D CT scan, you will have a single photon emission computed tomography (SPECT) pulmonary (lung) ventilation scan performed. The SPECT ventilation scan requires that you first breathe in a radioactive aerosol (or mist, called Tc-99m DPTA), which will help the study doctor tell where air goes when you breathe. Then you will be placed in the SPECT scanner, and images will be taken of your lungs. The SPECT imaging will take about 1 hour to complete.

Within 10 days after the first imaging session, you will return for a second imaging session. During the second imaging session, you will have a standard of care SPECT pulmonary perfusion (blood supply to tissue and organs) test done. During this test, a radioactive substance is given by vein (called Tc-99m MAA). This substance will get trapped in the lungs, and the SPECT imaging will show the blood flow in the lungs. This test should take 45-60 minutes to complete.

Once you complete the second imaging session, your participation will over in this study.

This is an investigational study. All of the imaging scans used in this study are FDA approved and commercially available. The calculation of ventilation images from 4D CT scanning is investigational and authorized for use in research only. Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with pathologic diagnosis of esophagus or lung cancer (Stage I through IV).
  2. Patients must be able to lie flat for the duration of the treatment planning sessions.
  3. Patients must sign informed consent.
  4. Patients who are scheduled to receive radiation therapy.
  5. A cohort of 6 lung cancer patients whose primary tumors move greater than 1 cm will be recruited (CPAP cohort).

Exclusion Criteria:

  1. Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
  2. Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
  3. Patients with severe COPD or asthma will be excluded from the CPAP cohort.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 4-DCT Ventilation Validation
Procedure: 4D CT scans
Three 4D CT scans will be performed. After you are out of the CT scanner, ventilation images will be calculated from the 4D CT images and will be compared with the standard ventilation imaging method.
Procedure: Lung Function Imaging
Lung function imaging performed to provide information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Heath Skinner, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 21, 2007

Primary Completion (ACTUAL)

September 21, 2018

Study Completion (ACTUAL)

September 21, 2018

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (ESTIMATE)

September 18, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0698
  • R21CA128230 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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