Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain

October 2, 2012 updated by: Toshiba America Medical Systems, Inc.

ROMAN (PCA-9000A) PET/CT System Verification

The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.

Study Overview

Status

Unknown

Conditions

Detailed Description

Scope:

To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.

  • Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
  • Verification of the quantitative accuracy of the imaging chain.
  • Evaluate the performance and stability of the new system and its related quality control and calibration procedures.

Result (Expected):

The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Steinberg Diagnostic Medical Imaging Centers
        • Contact:
          • Jim Kelley
          • Phone Number: 702-240-1215
        • Principal Investigator:
          • Mark L Winkler, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients already scheduled for a FDG test.

Description

Inclusion:

  • Patients already scheduled for an FDG test at SDMI
  • 40 years and older
  • Adult must be able to sign an informed consent form

Exclusion

  • Patients not scheduled for an FDG test at SDMI
  • 39 years or younger
  • Pregnant adult female or plan to be pregnant
  • Adult who is unable to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toshiba America Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ROMAN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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