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

This study has been completed.
University Hospitals Cleveland Medical Center
Case Western Reserve University
IMARC Research
Information provided by (Responsible Party):
Philips Healthcare Identifier:
First received: November 9, 2012
Last updated: September 30, 2016
Last verified: September 2016

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.

Condition Intervention
Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
Device: Additional PET Scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • 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.

Enrollment: 51
Study Start Date: November 2012
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01731860

United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Philips Healthcare
University Hospitals Cleveland Medical Center
Case Western Reserve University
IMARC Research
Principal Investigator: Peter F Faulhaber, MD University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Philips Healthcare Identifier: NCT01731860     History of Changes
Other Study ID Numbers: Alpha Ring 12-001
Study First Received: November 9, 2012
Last Updated: September 30, 2016

Keywords provided by Philips Healthcare:
Philips processed this record on May 25, 2017