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

This study is not yet open for participant recruitment.
Verified October 2012 by Toshiba America Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01701167
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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


Condition
Confirm PCA-9000A PET/CT System is Effective for Its Intended Use

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: ROMAN (PCA-9000A) PET/CT System Verification

Further study details as provided by Toshiba America Medical Systems, Inc.:

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

Patients already scheduled for a FDG test.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701167

Locations
United States, Nevada
Steinberg Diagnostic Medical Imaging Centers Not yet recruiting
Henderson, Nevada, United States, 89052
Contact: Jim Kelley    702-240-1215      
Principal Investigator: Mark L Winkler, M.D.         
Sponsors and Collaborators
Toshiba America Medical Systems, Inc.
  More Information

No publications provided

Responsible Party: Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01701167     History of Changes
Other Study ID Numbers: ROMAN-01
Study First Received: October 2, 2012
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014