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Motion Correction of Positron Emission Tomography (PET) Data Using Amplitude Gating

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843219
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date February 12, 2009
First Posted Date February 13, 2009
Last Update Posted Date February 17, 2016
Study Start Date March 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2010)
Mean Difference Between Gated + Ungated PET/CT Scans [ Time Frame: Scheduled PET/CT scans extended by 10 minutes ]
Original Primary Outcome Measures
 (submitted: February 12, 2009)
To study if adjusting the PET scanner to allow for breathing motion can improve the quality of PET images. [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Motion Correction of Positron Emission Tomography (PET) Data Using Amplitude Gating
Official Title Motion Correction of Positron Emission Tomography (PET) Data Using Amplitude Gating
Brief 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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Lung Cancer
Intervention Procedure: PET/CT Scan
PET/CT scan performed with elastic belt around lower chest/upper abdomen to track breathing motion.
Other Names:
  • Positron Emission Tomography
  • Positron Emission Tomography/Computed Tomography
  • Computed Tomography
Study Groups/Cohorts PET/CT Scan
Intervention: Procedure: PET/CT Scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2012)
12
Original Estimated Enrollment
 (submitted: February 12, 2009)
10
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with lung or liver lesions measuring 0.5-2cm in diameter will be considered.
  2. Patients that are scheduled to be imaged in the PET/CT suite at the Mays Building will only be considered.

Exclusion Criteria:

  1. Pediatric patients (younger than 18 years) will be excluded.
  2. Patients that cannot tolerate being scanned for an additional 10 minutes with arms above their head will be excluded.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00843219
Other Study ID Numbers 2008-0851
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators GE Healthcare
Investigators
Principal Investigator: Osama R Mawlawi, PHD UT MD Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date January 2012