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

This study has been completed.

Sponsor:

Collaborators:

University Hospitals Cleveland 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: September 30, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2012

Last Updated Date

September 30, 2016

Start Date ^ICMJE

November 2012

Primary Completion Date

July 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01731860 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.

Intervention ^ICMJE

Device: Additional PET Scan

Additional PET Scan with no additional radiopharmaceutical administration.

Study Arms

Experimental: Patients receiving PET/CT

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

Intervention: Device: Additional PET Scan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

July 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01731860

Other Study ID Numbers ^ICMJE

Alpha Ring 12-001

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Philips Healthcare

Study Sponsor ^ICMJE

Philips Healthcare

Collaborators ^ICMJE

University Hospitals Cleveland Medical Center
Case Western Reserve University
IMARC Research

Investigators ^ICMJE

Principal Investigator:

Peter F Faulhaber, MD

University Hospitals Cleveland Medical Center

PRS Account

Philips Healthcare

Verification Date

September 2016

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

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