Lung CancerNCT00843219
Motion Correction of Positron Emission Tomography (PET) Data Using Amplitude Gating
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: Evaluation of an amplitude based gated Positron Emission Tomography (PET) data acquisition system for all GE Discovery Positron Emission Tomography/ Computed Tomography (PET/CT) scanners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- PET/CT Scan
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2011
- Phase
- Observational
- 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
Study population: Individuals over the age of 18 with non-small cell lung cancer (NSCLC) and are scheduled to have a positron emission tomography/computed tomography (PET/CT) scan.
Who may be able to join
- Patients with lung or liver lesions measuring 0.5-2cm in diameter will be considered.
- Patients that are scheduled to be imaged in the PET/CT suite at the Mays Building will only be considered.
Who cannot join
- Pediatric patients (younger than 18 years) will be excluded.
- Patients that cannot tolerate being scanned for an additional 10 minutes with arms above their head will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives:
Evaluation of an amplitude based gated Positron Emission Tomography (PET) data acquisition system for all GE Discovery Positron Emission Tomography/ Computed Tomography (PET/CT) scanners.
Read the detailed description
Routine PET/CT scans are taken while patients are breathing normally. The motions made by breathing can reduce the image quality of the scan. Minimizing the effects of this motion by taking the images and processing the scans differently may improve the image quality.
The PET/CT Scan:
If you agree to take part in this study, an elastic belt will be placed around your lower chest/upper abdomen before your routine PET/CT scan. This belt is used to track your breathing motion. This information will be used to help process the scan.
Your PET/CT scan will be performed as usual. During the scan, researchers will focus on your lower chest/upper abdomen (areas that experience breathing motion). Having to focus on this area might extend the scan by up to 10 minutes.
The additional scan time will not increase your radiation exposure since only PET scanning will be performed.
Length of Study:
Your participation on this study will be complete when your scheduled PET/CT scan is complete.
This is an investigational study. The imaging focused on your lower chest/upper abdomen during the scan is investigational.
Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- PET/CT Scan
- Keywords
- Lung, Lung Cancer, Non-small cell Lung Cancer, NSCLC, Motion Correction, PET/CT Scan, PET, Positron Emission Tomography, CT, Computed Tomography, Amplitude Gating
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ScanProcedure or surgery
Also called Positron Emission Tomography, Positron Emission Tomography/Computed Tomography, Computed Tomography
PET/CT scan performed with elastic belt around lower chest/upper abdomen to track breathing motion.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT Scan | Not described Receives: Procedure: PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference Between Gated + Ungated PET/CT Scans
Measured: Scheduled PET/CT scans extended by 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Osama R Mawlawi, PHD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843219
- Sponsor's protocol ID
- 2008-0851
- Status last verified
- Jan 2012
- First submitted
- 12 Feb 2009
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Correction of Positron Emission Tomography (PET) Data Using Amplitude Gating
- ClinicalTrials.gov ID
- NCT00843219
- Acronym / sponsor ID
- 2008-0851
- Conditions
- Lung Cancer
- Keywords
- Lung, Lung Cancer, Non-small cell Lung Cancer, NSCLC, Motion Correction, PET/CT Scan, PET, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Feb 2009 (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:
Evaluation of an amplitude based gated Positron Emission Tomography (PET) data acquisition system for all GE Discovery Positron Emission Tomography/ Computed Tomography (PET/CT) scanners.
Detailed description
Routine PET/CT scans are taken while patients are breathing normally. The motions made by breathing can reduce the image quality of the scan. Minimizing the effects of this motion by taking the images and processing the scans differently may improve the image quality.
The PET/CT Scan:
If you agree to take part in this study, an elastic belt will be placed around your lower chest/upper abdomen before your routine PET/CT scan. This belt is used to track your breathing motion. This information will be used to help process the scan.
Your PET/CT scan will be performed as usual. During the scan, researchers will focus on your lower chest/upper abdomen (areas that experience breathing motion). Having to focus on this area might extend the scan by up to 10 minutes.
The additional scan time will not increase your radiation exposure since only PET scanning will be performed.
Length of Study:
Your participation on this study will be complete when your scheduled PET/CT scan is complete.
This is an investigational study. The imaging focused on your lower chest/upper abdomen during the scan is investigational.
Up to 26 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Scan | – | Procedure: PET/CT Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over the age of 18 with non-small cell lung cancer (NSCLC) and are scheduled to have a positron emission tomography/computed tomography (PET/CT) scan.
Key inclusion criteria (2 listed)
- Patients with lung or liver lesions measuring 0.5-2cm in diameter will be considered.
- Patients that are scheduled to be imaged in the PET/CT suite at the Mays Building will only be considered.
Key exclusion criteria (2 listed)
- Pediatric patients (younger than 18 years) will be excluded.
- Patients that cannot tolerate being scanned for an additional 10 minutes with arms above their head will be excluded.
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 |
|---|---|---|
| PET/CT ScanAlso: Positron Emission Tomography, Positron Emission Tomography/Computed Tomography, Computed TomographyPET/CT scan performed with elastic belt around lower chest/upper abdomen to track breathing motion. | Procedure or surgery | PET/CT Scan |
Primary outcome
Mean Difference Between Gated + Ungated PET/CT Scans
Time frame: Scheduled PET/CT scans extended by 10 minutes
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 17 Feb 2016.
- UT MD Anderson Cancer CenterLink 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.
Osama R Mawlawi, 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?
An observational study of 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 2 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 17 Feb 2016. 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.
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?
Mean Difference Between Gated + Ungated PET/CT Scans (time frame: Scheduled PET/CT scans extended by 10 minutes). 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 17 Feb 2016.