Pilot Study Intended to Provide Input for Future Designs... | NCT01731860

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

NCT01731860

Sponsor

Philips Healthcare

Status

Completed

Last Update Posted

Oct 4, 2016Estimated

Enrollment

51Actual

Phase

Not Applicable

Conditions

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

Interventions

Additional PET Scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Nov 9, 2012

First Submission Date that Met QC Criteria

Nov 21, 2012

First Posted Date

Nov 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2016

Last Update Posted Date

Oct 4, 2016Estimated

Name	Class
University Hospitals Cleveland Medical Center	OTHER
Case Western Reserve University	OTHER
Imarc Research, Inc.	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving PET/CT	Experimental	Patients already scheduled for a clinically necessary PET/CT scan.	Device: Additional PET Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Additional PET Scan	Device	Additional PET Scan with no additional radiopharmaceutical administration.	Patients receiving PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Imaging Capabilities and Performance of the Alpha Ring	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.	Within 1 month of image acquisition

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter F Faulhaber, MD	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Case Medical Center		Cleveland	Ohio	44106	United States

Type	Date	Date Unknown
Release	Jul 7, 2017
Reset	Aug 1, 2017
Release	Aug 21, 2017
Reset	Sep 18, 2017
Release	Mar 9, 2020
Reset	Mar 20, 2020
Release	Feb 7, 2022
Reset	Mar 1, 2022

Submission Tracking

Estimated Results First Submitted Date

Jul 7, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 7, 2017			Aug 1, 2017
Aug 21, 2017