NCT01731860

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

October 4, 2016

Status Verified

September 1, 2016

Enrollment Period

3.7 years

First QC Date

November 9, 2012

Last Update Submit

September 30, 2016

Conditions

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

Keywords

PET/CTPhilips

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients receiving PET/CT

EXPERIMENTAL

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

Device: Additional PET Scan

Interventions

Additional PET ScanDEVICE

Additional PET Scan with no additional radiopharmaceutical administration.

Patients receiving PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are at least 18 years
  • Patients are medically stable
  • Patients scheduled for clinically necessary PET/CT examination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

  • Peter F Faulhaber, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 22, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-09

Locations

US(1)