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

Toshiba Medical Systems

Status: Unknown

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01701167

ROMAN-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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