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

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

Official title:

ROMAN (PCA-9000A) PET/CT System Verification

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01701167
• Other study ID #: ROMAN-01
• Status: Not yet recruiting
• Phase: N/A
• First received: October 2, 2012
• Last updated: October 2, 2012
• Start date: November 2012

Study information

• Verified date: October 2012
• Source: Toshiba America Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2013
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Steinberg Diagnostic Medical Imaging Centers	Henderson	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Toshiba America Medical Systems, Inc.

Country where clinical trial is conducted

United States,