HealthyNCT00088361
Effect of Respiratory Motion on Positron Emission Tomography Imaging
An observational study of Healthy and Tomography, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will determine how breathing motions may affect positron emission tomography (PET) scans. It has been discovered that the quality of PET scans varies according to which part of the breathing cycle patients hold their breath. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Healthy, Tomography, Emission Computed
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2006
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Up to 30 subjects will take part in the study, chosen from sequential incoming clinical patients who are scheduled for PET/CT studies of the torso and who have had or will have a diagnostic CT within one week of the PET/CT study, without regard to disease. The number of subjects selected for study per week will depend on patient load and availability of scanner and technologist). Approximately an equal number of males and females will be selected by alternating each selection between male and female. The selection of subjects asked to participate will be random, in the sense that whenever technologist and analysis time is available, the next subject scheduled for a whole body scan will be asked to participate.
Who cannot join
- The only exclusion criteria will be subjects with respiratory difficulties.
- Children under the age of 12.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: The Effects of Respiratory Motion on CT Based Attenuation Correction of Positron Emission Tomography Data: Liver and Heart Studies
This study will determine how breathing motions may affect positron emission tomography (PET) scans. It has been discovered that the quality of PET scans varies according to which part of the breathing cycle patients hold their breath.
NIH Clinical Center patients 12 years of age and older who are scheduled to have PET and computed tomography (CT) scans as part of their standard medical care may be eligible for this study.
Read more
Participants have their scheduled PET or CT scan as they normally would and are asked to hold their breath after breathing out, as is usual. In addition, for this study, patients are also asked hold their breath after breathing in and again at a point between breathing in and out. Each breath-hold is for around 15 seconds. The scans for each of the three different breath-holds are examined for differences.
Some patients may also be asked to breathe through a tube called a pneumotachometer, or spirometer, to determine their normal breathing pattern. This involves breathing through a mouthpiece similar to a snorkel mouthpiece and takes about 2 minutes.
Read the detailed description
Current clinical FDG imaging with the NIH's PET/CT machine (and in fact with most commercial PET/CT machines) requires a CT scan be acquired prior to the PET scan. This CT scan is used for attenuation correction of the PET data and to permit fusion of anatomical and metabolic image data.
One difficulty with use of the CT scan for attenuation correction ('CTAC') is that the CT scan is rapid compared to the breathing cycle. Each CT slice captures the lungs at one (usually arbitrary) phase of the respiratory cycle. The PET data on the other hand take many minutes to acquire, and so average the motion effects of the entire respiratory cycle together. This 'freezing' of the respiratory cycle by the CT, and blurring of the respiratory cycle during PET produces a mis-match between the PET and CT data. This mis-match can produce improper attenuation correction during PET reconstruction, especially at soft tissue/lung interfaces. The existence of this phenomenon has been reported in the literature [1-7], especially at the dome of the liver, but it has not been thoroughly quantified. Little or no data is available to indicate the quantitative errors the effect produces in cardiac imaging[8]. This despite the fact that the myocardium is only about 10mm thick, and it has been reported that the heart moves on average 9mm (and as much as 14mm) during a single average respiratory cycle[9].
The purpose of this protocol is to determine the degree to which respiratory motion may influence quantitative PET imaging, especially at the lung/liver interface and free wall of myocardium. By characterizing the magnitude of the effect, we hope to gain knowledge about when correction for the effect is and is not necessary. It is hoped that the information gained will also allow us to suggest potential methods to perform such corrections.
To gain the above information we will modify the CT acquisition protocol for subjects already scheduled to undergo a whole body FDG PET/CT scan. In summary, rather than acquiring the usual single full radiation exposure CT (taking approx 20-30 seconds), we will acquire 3 CT scans (each taking approximately 20-30 seconds), each at 1/3 the usual radiation exposure. Each CT will be acquired at a different phase of the respiratory cycle (as opposed to current acquisition, which is only at end-expiration). The subsequent PET data will be acquired as usual, but will be processed and analyzed separately with each of the CT scans and also with a summed CT scan.
Note that subjects agreeing to participate in this protocol will receive no additional radiation exposure. Participation in the protocol will extend the current overall scan time (typically greater than 45 minutes) a very small amount (about 40-60 additional seconds for imaging, and about 60 additional seconds for patient set up, etc).
- Conditions
- Healthy, Tomography, Emission Computed
- Keywords
- Reconstruction, PET Artifacts, PET/CT Motion Artifacts, Liver, Heart, Respiratory Motion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startJul 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088361
- Sponsor's protocol ID
- 040237
- Other IDs
- 04-CC-0237
- Status last verified
- Jun 2006
- First submitted
- 23 Jul 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Osman MM, Cohade C, Nakamoto Y, Wahl RL. Respiratory motion artifacts on PET emission images obtained using CT attenuation correction on PET-CT. Eur J Nucl Med Mol Imaging. 2003 Apr;30(4):603-6. doi: 10.1007/s00259-002-1024-x. Epub 2003 Jan 21.
PubMed 12536242
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Respiratory Motion on CT Based Attenuation Correction of Positron Emission Tomography Data: Liver and Heart Studies
- ClinicalTrials.gov ID
- NCT00088361
- Acronym / sponsor ID
- 040237
- Conditions
- Healthy, Tomography, Emission Computed
- Keywords
- Reconstruction, PET Artifacts, PET/CT Motion Artifacts, Liver, Heart, Respiratory Motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jul 2004
- Study completion
- Jun 2006
- First posted
- 26 Jul 2004 (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.
This study will determine how breathing motions may affect positron emission tomography (PET) scans. It has been discovered that the quality of PET scans varies according to which part of the breathing cycle patients hold their breath.
NIH Clinical Center patients 12 years of age and older who are scheduled to have PET and computed tomography (CT) scans as part of their standard medical care may be eligible for this study.
Participants have their scheduled PET or CT scan as they normally would and are asked to hold their breath after breathing out, as is usual. In addition, for this study, patients are also asked hold their breath after breathing in and again at a point between breathing in and out. Each breath-hold is for around 15 seconds. The scans for each of the three different breath-holds are examined for differences.
Some patients may also be asked to breathe through a tube called a pneumotachometer, or spirometer, to determine their normal breathing pattern. This involves breathing through a mouthpiece similar to a snorkel mouthpiece and takes about 2 minutes.
Detailed description
Current clinical FDG imaging with the NIH's PET/CT machine (and in fact with most commercial PET/CT machines) requires a CT scan be acquired prior to the PET scan. This CT scan is used for attenuation correction of the PET data and to permit fusion of anatomical and metabolic image data.
One difficulty with use of the CT scan for attenuation correction ('CTAC') is that the CT scan is rapid compared to the breathing cycle. Each CT slice captures the lungs at one (usually arbitrary) phase of the respiratory cycle. The PET data on the other hand take many minutes to acquire, and so average the motion effects of the entire respiratory cycle together. This 'freezing' of the respiratory cycle by the CT, and blurring of the respiratory cycle during PET produces a mis-match between the PET and CT data. This mis-match can produce improper attenuation correction during PET reconstruction, especially at soft tissue/lung interfaces. The existence of this phenomenon has been reported in the literature [1-7], especially at the dome of the liver, but it has not been thoroughly quantified. Little or no data is available to indicate the quantitative errors the effect produces in cardiac imaging[8]. This despite the fact that the myocardium is only about 10mm thick, and it has been reported that the heart moves on average 9mm (and as much as 14mm) during a single average respiratory cycle[9].
The purpose of this protocol is to determine the degree to which respiratory motion may influence quantitative PET imaging, especially at the lung/liver interface and free wall of myocardium. By characterizing the magnitude of the effect, we hope to gain knowledge about when correction for the effect is and is not necessary. It is hoped that the information gained will also allow us to suggest potential methods to perform such corrections.
To gain the above information we will modify the CT acquisition protocol for subjects already scheduled to undergo a whole body FDG PET/CT scan. In summary, rather than acquiring the usual single full radiation exposure CT (taking approx 20-30 seconds), we will acquire 3 CT scans (each taking approximately 20-30 seconds), each at 1/3 the usual radiation exposure. Each CT will be acquired at a different phase of the respiratory cycle (as opposed to current acquisition, which is only at end-expiration). The subsequent PET data will be acquired as usual, but will be processed and analyzed separately with each of the CT scans and also with a summed CT scan.
Note that subjects agreeing to participate in this protocol will receive no additional radiation exposure. Participation in the protocol will extend the current overall scan time (typically greater than 45 minutes) a very small amount (about 40-60 additional seconds for imaging, and about 60 additional seconds for patient set up, etc).
Study design
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Up to 30 subjects will take part in the study, chosen from sequential incoming clinical patients who are scheduled for PET/CT studies of the torso and who have had or will have a diagnostic CT within one week of the PET/CT study, without regard to disease. The number of subjects selected for study per week will depend on patient load and availability of scanner and technologist). Approximately an equal number of males and females will be selected by alternating each selection between male and female. The selection of subjects asked to participate will be random, in the sense that whenever technologist and analysis time is available, the next subject scheduled for a whole body scan will be asked to participate.
Key exclusion criteria (2 listed)
- The only exclusion criteria will be subjects with respiratory difficulties.
- Children under the age of 12.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 12536242Osman MM, Cohade C, Nakamoto Y, Wahl RL. Respiratory motion artifacts on PET emission images obtained using CT attenuation correction on PET-CT. Eur J Nucl Med Mol Imaging. 2003 Apr;30(4):603-6. doi: 10.1007/s00259-002-1024-x. Epub 2003 Jan 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy and Tomography, run by National Institutes of Health Clinical Center (CC) 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 1 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088361, which also lists 1 linked publication.
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 4 Mar 2008.