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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01701167
Enrollment
30
Registered
2012-10-04
Start date
2012-11-30
Completion date
Unknown
Last updated
2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Toshiba America Medical Systems, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026