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


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N/A
N/A
Open (Enrolling)
Both
Esophageal Cancer, Lung Cancer

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Trial Information

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


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.

Before you can start this study, you may have a "screening test." This test will help the
doctor decide if you are eligible to take part in this study. Women who are able to have
children must have a negative blood (about 2 teaspoons) pregnancy test.

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Thomas Guerrero, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0698

NCT ID:

NCT00531180

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Lung Cancer
  • Esophageal Cancer
  • Lung Cancer
  • Thoracic Malignancies
  • 4D CT scans
  • Lung Function
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms

Name

Location
U.T.M.D. Anderson Cancer Center Houston, Texas  77030