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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Steinberg Diagnostic Medical Imaging Centers

Henderson, Nevada, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jim Kelley

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROMAN-01

Identifier Type: -

Identifier Source: org_study_id