Verification of Imaging System PCD-1000A

Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain.

* Define and confirm all supported clinical protocols * Evaluate performance

Completed

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Key information

Conditions

Cancer Patients

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steinberg Diagnostic Medical Imaging Centers

Henderson, Nevada, 89052, United States

About this study

The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients already scheduled for an FDG test at SDMI
40 years and older
Capable of providing their informed consent

Exclusion criteria

Patients not scheduled for an FDG test at SDMI
39 years or younger
Adult female patients that are and/or could become pregnant
Not capable of providing their informed consent

Treatment and study plan

PET/CT imaging

Device

Subjects will be have a PET/CT scan with PCD-1000A following their scheduled routine PET/CT scan. There will be no additional administration of radiopharmaceutical for the study.

Primary outcomes

Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use

Time frame: 3 months
PCD-1000A PET/CT system's performance will be evaluated for oncology PET imaging on cancer patients to verify that the system performs as expected.
- Verify that all supported clinical protocols from PET acquisition, reconstruction, to presentation (filtering) perform as expected. Images acquired by PCD-1000A PET/CT will be compared with images acquired during a standard-of-care PET/CT scan by a commercially available PET/CT system just prior to imaging with the PCD-1000A PET/CT System. Image quality evaluation will include assessment of uniformity of the liver, delineation of the lungs, presence of artifacts and using Likert scale.

Sponsors and collaborators

Lead sponsor

Canon Medical Systems, USA

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jul 18, 2019
Registry last updated: Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed