Esophageal CancerPhase 2NCT00531180
4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies
A Phase 2 study testing 4D CT scans and Lung Function Imaging in people with Esophageal Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer, Lung Cancer
- What is being tested?
- 4D CT scans and Lung Function Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2007to 21 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pathologic diagnosis of esophagus or lung cancer (Stage I through IV).
- Patients must be able to lie flat for the duration of the treatment planning sessions.
- Patients must sign informed consent.
- Patients who are scheduled to receive radiation therapy.
- A cohort of 6 lung cancer patients whose primary tumors move greater than 1 cm will be recruited (CPAP cohort).
Who cannot join
- Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
- 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.
- Patients with severe COPD or asthma will be excluded from the CPAP cohort.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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:
- 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:
- To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting.
- To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies.
- To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.
Read the 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.
- Conditions
- Esophageal Cancer, Lung Cancer
- Being tested
- 4D CT scans, Lung Function Imaging
- Keywords
- Esophageal Cancer, Lung Cancer, Thoracic Malignancies, 4D CT scans, Lung Function
- Medical subject headings
- Esophageal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D CT scansProcedure or surgery
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 ImagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 4-DCT Ventilation Validation | Experimental | Not described Receives: Procedure: 4D CT scans; Procedure: Lung Function Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study start21 Aug 2007
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heath Skinner, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531180
- Sponsor's protocol ID
- 2006-0698
- Other IDs
- R21CA128230
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2007
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Comparing 4-Dimensional Computed Tomography Derived Ventilation Versus SPECT/CT Tc-99m Aerosol Ventilation in Patients With Thoracic Malignancies
- ClinicalTrials.gov ID
- NCT00531180
- Acronym / sponsor ID
- 2006-0698
- Conditions
- Esophageal Cancer, Lung Cancer
- Keywords
- Esophageal Cancer, Lung Cancer, Thoracic Malignancies, 4D CT scans, Lung Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Aug 2007 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Primary Objective:
- 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:
- To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting.
- To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies.
- To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-DCT Ventilation Validation | Experimental | Procedure: 4D CT scans, Procedure: Lung Function Imaging |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pathologic diagnosis of esophagus or lung cancer (Stage I through IV).
- Patients must be able to lie flat for the duration of the treatment planning sessions.
- Patients must sign informed consent.
- Patients who are scheduled to receive radiation therapy.
- A cohort of 6 lung cancer patients whose primary tumors move greater than 1 cm will be recruited (CPAP cohort).
Key exclusion criteria (3 listed)
- Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
- 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.
- Patients with severe COPD or asthma will be excluded from the CPAP cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D CT scansThree 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 or surgery | 4-DCT Ventilation Validation |
| Lung Function ImagingLung 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. | Procedure or surgery | 4-DCT Ventilation Validation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heath Skinner, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4D CT scans and Lung Function Imaging in people with Esophageal Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.