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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

October 2, 2012
October 2, 2012
November 2012
February 2013   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients already scheduled for a FDG test.

Confirm PCA-9000A PET/CT System is Effective for Its Intended Use
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Not Provided
United States
 
NCT01701167
ROMAN-01
No
Toshiba America Medical Systems, Inc.
Toshiba America Medical Systems, Inc.
Not Provided
Not Provided
Toshiba America Medical Systems, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP