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

Not Applicable

Completed

• Conditions: Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
• Interventions: Device: Additional PET Scan

• Registration Number: NCT01731860
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Primary Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving PET/CT	Additional PET Scan	Patients already scheduled for a clinically necessary PET/CT scan.

Primary Outcome Measures

Name	Time	Method
Imaging Capabilities and Performance of the Alpha Ring	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.

Trial Locations

Locations (1)

University Hospital Case Medical Center; 🇺🇸 Cleveland, Ohio, United States