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

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ClinicalTrials.gov Identifier: NCT01701167
Recruitment Status : Unknown
Verified October 2012 by Toshiba America Medical Systems, Inc..
Recruitment status was:  Not yet recruiting
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Toshiba America Medical Systems, Inc.

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

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

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
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: ROMAN (PCA-9000A) PET/CT System Verification
Study Start Date : November 2012
Estimated Primary Completion Date : February 2013




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01701167     History of Changes
Other Study ID Numbers: ROMAN-01
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012