Esophagus CancerPhase 1NCT01626001
Imaging Study Compare 4DCT Image
A Phase 1 study testing 4D CT scans in people with Esophagus Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn about ways to possibly reduce scanning errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in patients with esophageal or lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Lung Cancer
- What is being tested?
- 4D CT scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2014
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must sign consent for the study.
- Patients with pathologic diagnosis of esophagus or lung cancer.
- Patient who plan to receive radiation therapy treatment at MD Anderson.
- Patient >/=18 years of age
Who cannot join
- Presence of an implanted electronic device.
- Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant.
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: An Imaging Study to Compare Methods to Reduce 4DCT Image Acquisition Artifacts
The goal of this clinical research study is to learn about ways to possibly reduce scanning errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in patients with esophageal or lung cancer.
Read the detailed description
Study Procedure:
By using 4D CT scans, researchers can create images that show how air moves through the lungs. This new method to check lung function may make better images than the standard methods. Researchers will compare 4 images of how air moves through your lungs and 1 image while you hold your breath.
Study Groups:
If you are found to be eligible to take part in this study (if the screening test is applicable) and you agree to take part in this study, you will be enrolled in 1 of 2 study groups, depending on when you join the study. There will be up to 18 participants in each group. In the first group, researchers will test several different methods to create images of how air moves through the lungs. Researchers will then select the most successful methods from the first group and try to do them again with the second group.
Study Visits:
You will have up to two visits for this study. At these visits, you will have four 4DCT scans performed (for Group 1) or five scans (for Group 2) using both the 4DCT and spiral CT, while you are breathing normally. You will also have 1 scan while you hold your breath for less than 20 seconds. The CT scans will take about 5 minutes each to complete. If the spiral CT scans for Group 2 cannot be completed on the same day as the 4DCT scans, you will be asked for your willingness to return at a later day to complete these.
The 4D CT scan will cover the entire chest area using the standard dose of radiation. A 2-inch plastic box will be placed on top of your chest to track the motion of your chest while you breathe during each scan. Some parts of your chest will be scanned up to 2 more times based on your breathing.
The entire scanning session will take about 45 minutes to complete.
Length of Participation:
Your active participation on the study will be over when you have completed your study visit.
Follow-Up Phone Call:
Within 7 days after your last study visit, the study staff will call you to ask about any side effects you may be having. This call should last about 2 minutes.
If anything unusual is found in the imaging, your cancer doctor will be told so that you can receive follow-up.
This is an investigational study. The CT scans used in this study are delivered using FDA-approved and commercially available systems. Creating images of how air moves through the lungs from 4D CT scans is considered investigational.
Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Esophagus Cancer, Lung Cancer
- Being tested
- 4D CT scans
- Keywords
- Esophagus Cancer, Lung Cancer, 4-dimensional computed tomography, 4D CT
- 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
Also called CT, X-ray, Computed Tomography
4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort of 18 subjects evaluated. Subject will receive 4DCT cine acquisition gated using a respiratory signal from real-time position management (RPM) gating system. Maximum number of allowable images that may be acquired increased from 3000 to 5999 images. Total imaging time for each subject < 60 minutes. Receives: Procedure: 4D CT scans |
| Cohort 2 | Experimental | Reproducibility of optimal 4DCT acquisition method determined from cohort 1 tested with cohort of 18 study subjects. Three 4DCT images acquired, all with acquisition method determined from cohort 1. Cohort also receives two spiral-mode 4DCT acquisitions. Receives: Procedure: 4D CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Percentage with 4DCT Acquisition Artifacts
Primary statistical analysis is intra-subject comparison of artifacts versus acquisition methods. In cohort 1: 4DCT acquisition techniques consist of 1) baseline acquisition, 2) extended acquisition, 3) real-time acquisition gating, and 4) re-imaging of bad segments. An automated computer scoring system, as described by Han et al., will be implemented and validated using the first 5 cases. To quantify 4DCT image quality, number and anatomic misplacement distance of artifacts will be measured, for each set of acquisition methods and each subject.
Measured: 1 day
Secondary outcomes (1)
Artifact Reproducibility Reducing 4DCT Acquisition
Winning acquisition method with lowest average misplacement per subject selected for evaluation of reproducibility. Goal is to quantify intra-subject variance for selected winning 4DCT acquisition method on image parameters significant for calculation of 4DCT ventilation images. Both acquisition artifacts and physiological parameters (global average HU, ΔHU, the tidal volumes, and the lung mass) assessed for reproducibility with evaluation of mean and variance.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Thomas Guerrero, MD,PHD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626001
- Sponsor's protocol ID
- 2011-0631
- Other IDs
- 1dp20D007044-01
- Status last verified
- Aug 2014
- First submitted
- 20 Jun 2012
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging Study to Compare Methods to Reduce 4DCT Image Acquisition Artifacts
- ClinicalTrials.gov ID
- NCT01626001
- Acronym / sponsor ID
- 2011-0631
- Conditions
- Esophagus Cancer, Lung Cancer
- Keywords
- Esophagus Cancer, Lung Cancer, 4-dimensional computed tomography, 4D CT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jun 2012 (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.
The goal of this clinical research study is to learn about ways to possibly reduce scanning errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in patients with esophageal or lung cancer.
Detailed description
Study Procedure:
By using 4D CT scans, researchers can create images that show how air moves through the lungs. This new method to check lung function may make better images than the standard methods. Researchers will compare 4 images of how air moves through your lungs and 1 image while you hold your breath.
Study Groups:
If you are found to be eligible to take part in this study (if the screening test is applicable) and you agree to take part in this study, you will be enrolled in 1 of 2 study groups, depending on when you join the study. There will be up to 18 participants in each group. In the first group, researchers will test several different methods to create images of how air moves through the lungs. Researchers will then select the most successful methods from the first group and try to do them again with the second group.
Study Visits:
You will have up to two visits for this study. At these visits, you will have four 4DCT scans performed (for Group 1) or five scans (for Group 2) using both the 4DCT and spiral CT, while you are breathing normally. You will also have 1 scan while you hold your breath for less than 20 seconds. The CT scans will take about 5 minutes each to complete. If the spiral CT scans for Group 2 cannot be completed on the same day as the 4DCT scans, you will be asked for your willingness to return at a later day to complete these.
The 4D CT scan will cover the entire chest area using the standard dose of radiation. A 2-inch plastic box will be placed on top of your chest to track the motion of your chest while you breathe during each scan. Some parts of your chest will be scanned up to 2 more times based on your breathing.
The entire scanning session will take about 45 minutes to complete.
Length of Participation:
Your active participation on the study will be over when you have completed your study visit.
Follow-Up Phone Call:
Within 7 days after your last study visit, the study staff will call you to ask about any side effects you may be having. This call should last about 2 minutes.
If anything unusual is found in the imaging, your cancer doctor will be told so that you can receive follow-up.
This is an investigational study. The CT scans used in this study are delivered using FDA-approved and commercially available systems. Creating images of how air moves through the lungs from 4D CT scans is considered investigational.
Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Procedure: 4D CT scansCohort of 18 subjects evaluated. Subject will receive 4DCT cine acquisition gated using a respiratory signal from real-time position management (RPM) gating system. Maximum number of allowable images that may be acquired increased from 3000 to 5999 images. Total imaging time for each subject < 60 minutes. |
| Cohort 2 | Experimental | Procedure: 4D CT scansReproducibility of optimal 4DCT acquisition method determined from cohort 1 tested with cohort of 18 study subjects. Three 4DCT images acquired, all with acquisition method determined from cohort 1. Cohort also receives two spiral-mode 4DCT acquisitions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must sign consent for the study.
- Patients with pathologic diagnosis of esophagus or lung cancer.
- Patient who plan to receive radiation therapy treatment at MD Anderson.
- Patient >/=18 years of age
Key exclusion criteria (2 listed)
- Presence of an implanted electronic device.
- Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant.
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 scansAlso: CT, X-ray, Computed Tomography4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete. | Procedure or surgery | Cohort 1, Cohort 2 |
Primary outcome
Patient Percentage with 4DCT Acquisition Artifacts
Time frame: 1 day
Primary statistical analysis is intra-subject comparison of artifacts versus acquisition methods. In cohort 1: 4DCT acquisition techniques consist of 1) baseline acquisition, 2) extended acquisition, 3) real-time acquisition gating, and 4) re-imaging of bad segments. An automated computer scoring system, as described by Han et al., will be implemented and validated using the first 5 cases. To quantify 4DCT image quality, number and anatomic misplacement distance of artifacts will be measured, for each set of acquisition methods and each subject.
1 secondary outcome
Artifact Reproducibility Reducing 4DCT Acquisition
Time frame: 1 day
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 18 Nov 2015.
- 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.
Thomas Guerrero, MD,PHD principal investigator
UT MD 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 1 study testing 4D CT scans in people with Esophagus 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 4 inclusion and 2 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 18 Nov 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Patient Percentage with 4DCT Acquisition Artifacts (time frame: 1 day). 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 18 Nov 2015.