Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00088361
Other study ID # 040237
Secondary ID 04-CC-0237
Status Completed
Phase N/A
First received July 23, 2004
Last updated March 3, 2008
Start date July 2004
Est. completion date June 2006

Study information

Verified date June 2006
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 7 Years and older
Eligibility - INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

The only exclusion criteria will be subjects with respiratory difficulties.

Children under the age of 12.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center (CC) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2003 Jan 21. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1