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
  Purpose

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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


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 ] [ 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.


Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  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 ClinicalTrials.gov identifier: NCT01731860

Contacts
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

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

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01731860     History of Changes
Other Study ID Numbers: Alpha Ring 12-001
Study First Received: November 9, 2012
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Healthcare:
PET/CT
Philips

ClinicalTrials.gov processed this record on July 24, 2014