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

• Conditions: Confirm PCA-9000A PET/CT System is Effective for Its Intended Use

• Registration Number: NCT01701167
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Last Update Submitted: 2012-10-02
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04
• Study Start: 2012-11
• Primary Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Steinberg Diagnostic Medical Imaging Centers; 🇺🇸 Henderson, Nevada, United States