Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system.
The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.
Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
Device: Additional PET Scan
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product|
- Imaging Capabilities and Performance of the Alpha Ring [ Time Frame: Within 1 month of image acquisition ] [ Designated as safety issue: No ]Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Patients receiving PET/CT
Patients already scheduled for a clinically necessary PET/CT scan.
Device: Additional PET Scan
Additional PET Scan with no additional radiopharmaceutical administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731860
|Contact: Peter F Faulhaber, MD||216-844-3107||Peter.Faulhaber@UHhospitals.org|
|Contact: Sonya Mihalus, RN, BSN, BA, CCRC||216-286-0757||Sonya.Mihalus@UHhospitals.org|
|United States, Ohio|
|University Hospital Case Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Peter F Faulhaber, MD 216-844-3107 Peter.Faulhaber@UHhospitals.org|
|Contact: Sonya Mihalus, RN, BSN, BA, CCRC 216-286-0757 Sonya.Mihalus@UHhospitals.org|
|Principal Investigator: Peter F Faulhaber, MD|
|Principal Investigator:||Peter F Faulhaber, MD||University Hospital Case Medical Center|