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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00531180
First received: September 14, 2007
Last updated: September 29, 2014
Last verified: September 2014

September 14, 2007
September 29, 2014
August 2007
November 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00531180 on ClinicalTrials.gov Archive Site
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4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies
Phase II Trial Comparing 4-Dimensional Computed Tomography Derived Ventilation Versus SPECT/CT Tc-99m Aerosol Ventilation in Patients With Thoracic Malignancies

The goal of this clinical research study is to compare a new lung function calculation method with 2 standard imaging methods.

A secondary goal is to evaluate the effect of airway pressure on lung function and tumor motion.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients diagnosed with esophageal or lung cancer.

  • Esophageal Cancer
  • Lung Cancer
  • 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.
4-DCT Ventilation Validation
Patients diagnosed with esophageal or lung cancer.
Interventions:
  • Procedure: 4D CT scans
  • Procedure: Lung Function Imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
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November 2016   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00531180
2006-0698, R21CA128230
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Thomas Guerrero, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP