Verification of Imaging System PCD-1000A

Completed

• Conditions: Cancer Patients
• Interventions: Device: PET/CT imaging

• Registration Number: NCT04024748
• Lead Sponsor: Canon Medical Systems, USA

Brief Summary

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

* Define and confirm all supported clinical protocols

* Evaluate performance

Detailed Description

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

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-10-22
• Primary Completion: 2019-11-26
• Study Completion: 2019-11-26
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients already scheduled for a FDG test	PET/CT imaging	Subjects will be selected from patients already scheduled for a routine FDG PET/CT test. Only adult patients, 40 years old or older, capable of providing their informed consent, will be selected. Any adult female patients that are pregnant and/or could become pregnant will be excluded. Twenty patients will be recruited.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Steinberg Diagnostic Medical Imaging Centers; 🇺🇸 Henderson, Nevada, United States