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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Philips Healthcare
Sponsor:
Collaborators:
University Hospital Case Medical Center
Case Western Reserve University
IMARC Research
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01731860
First received: November 9, 2012
Last updated: May 27, 2014
Last verified: May 2014

November 9, 2012
May 27, 2014
November 2012
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01731860 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients already scheduled for a clinically necessary PET/CT scan.

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.
Patients receiving PET/CT
Patients already scheduled for a clinically necessary PET/CT scan.
Intervention: Device: Additional PET Scan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
September 2014
September 2014   (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
Both
18 Years and older
No
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
 
NCT01731860
Alpha Ring 12-001
Yes
Philips Healthcare
Philips Healthcare
  • University Hospital Case Medical Center
  • Case Western Reserve University
  • IMARC Research
Principal Investigator: Peter F Faulhaber, MD University Hospital Case Medical Center
Philips Healthcare
May 2014

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