Verification of Imaging System PCD-1000A

• Sponsor: Canon Medical Systems, USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04024748
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 20.9

Study Details

Study Description

Brief Summary

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

• Define and confirm all supported clinical protocols

• Evaluate performance

Condition or Disease	Intervention/Treatment	Phase
Cancer Patients	Device: PET/CT imaging

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Verification of Imaging System PCD-1000A
• Actual Study Start Date: Oct 22, 2019
• Actual Primary Completion Date: Nov 26, 2019
• Actual Study Completion Date: Nov 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients already scheduled for a FDG test 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.	Device: PET/CT imaging; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Steinberg Diagnostic Medical Imaging Centers	Henderson	Nevada	United States	89052

Sponsors and Collaborators

• Canon Medical Systems, USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Canon Medical Systems, USA
• ClinicalTrials.gov Identifier: NCT04024748
• Other Study ID Numbers: PCD-1000A
• First Posted: Jul 18, 2019
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Aug 6, 2021