Effect of Respiratory Motion on Positron Emission Tomography Imaging
|First Received Date ICMJE||July 23, 2004|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||July 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00088361 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Respiratory Motion on Positron Emission Tomography Imaging|
|Official Title ICMJE||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.
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.
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. 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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||June 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
The only exclusion criteria will be subjects with respiratory difficulties.
Children under the age of 12.
|Ages||7 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00088361|
|Other Study ID Numbers ICMJE||040237
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP