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

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ClinicalTrials.gov Identifier: NCT01731860
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : October 4, 2016
Sponsor:
Collaborators:
University Hospitals Cleveland Medical Center
Case Western Reserve University
IMARC Research
Information provided by (Responsible Party):
Philips Healthcare

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.


Condition or disease Intervention/treatment Phase
Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology. Device: Additional PET Scan Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2012
Actual Primary Completion Date : July 2016

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731860


Locations
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
Investigators
Principal Investigator: Peter F Faulhaber, MD University Hospitals Cleveland Medical Center

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01731860     History of Changes
Other Study ID Numbers: Alpha Ring 12-001
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016

Keywords provided by Philips Healthcare:
PET/CT
Philips