We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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: NCT01731860
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):

November 9, 2012
November 22, 2012
October 4, 2016
November 2012
July 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01731860 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
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

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.

Not Provided
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
Device: Additional PET Scan
Additional PET Scan with no additional radiopharmaceutical administration.
Experimental: Patients receiving PET/CT
Patients already scheduled for a clinically necessary PET/CT scan.
Intervention: Device: Additional PET Scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Alpha Ring 12-001
Not Provided
Not Provided
Not Provided
Philips Healthcare
Philips Healthcare
  • University Hospitals Cleveland Medical Center
  • Case Western Reserve University
  • IMARC Research
Principal Investigator: Peter F Faulhaber, MD University Hospitals Cleveland Medical Center
Philips Healthcare
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP