Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector

Tracking Information
First Submitted Date ICMJE	November 9, 2012
First Posted Date ICMJE	November 22, 2012
Last Update Posted Date	October 4, 2016
Study Start Date ICMJE	November 2012
Actual Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 21, 2012)	Imaging Capabilities and Performance of the Alpha Ring [ Time Frame: Within 1 month of image acquisition ]; 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01731860 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
Descriptive Information
Brief Title ICMJE	Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
Intervention ICMJE	Device: Additional PET Scan; Additional PET Scan with no additional radiopharmaceutical administration.
Study Arms	Experimental: Patients receiving PET/CT; Patients already scheduled for a clinically necessary PET/CT scan.; Intervention: Device: Additional PET 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 ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 27, 2016)	51
Original Estimated Enrollment ICMJE; (submitted: November 21, 2012)	35
Study Completion Date	Not Provided
Actual Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients are at least 18 years; Patients are medically stable; Patients scheduled for clinically necessary PET/CT examination Exclusion Criteria: Patients who are pregnant; Patients who are unwilling/unable to sign the Informed Consent Form; Patients who are cognitively impaired and unable to provide informed consent; Patients who have experienced adverse events to PET/CT examinations
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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
Administrative Information
NCT Number ICMJE	NCT01731860
Other Study ID Numbers ICMJE	Alpha Ring 12-001
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Philips Healthcare
Study Sponsor ICMJE	Philips Healthcare
Collaborators ICMJE	University Hospitals Cleveland Medical Center; Case Western Reserve University; IMARC Research
Investigators ICMJE	Principal Investigator: Peter F Faulhaber, MD University Hospitals Cleveland Medical Center
PRS Account	Philips Healthcare
Verification Date	September 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP