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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-21

Study Completion Date

2018-09-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study of Regional Lung Ventilation

NCT03077113

Non-small Cell Lung Cancer

COMPLETED NA

Application of 4DCT-Based Pulmonary Ventilation Imaging in Lung Cancer Radiotherapy

NCT07312682

Lung Neoplasms Radiation Pneumonitis

ACTIVE_NOT_RECRUITING

Respiratory Tumor and Normal Tissue Motion

NCT00415675

Lung Cancer Abdominal Cancer

COMPLETED

Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

NCT03326570

Lung Cancer

COMPLETED

99mTc-H7ND SPECT/CT Imaging in NSCLC

NCT05999214

NSCLC

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4-DCT Ventilation Validation

Group Type EXPERIMENTAL

4D CT scans

Intervention Type PROCEDURE

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.

Lung Function Imaging

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No