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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Toshiba America Medical Systems, Inc..
Recruitment status was  Not yet recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014