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

Study Overview

• Status: Completed
• Conditions: Cancer Patients
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Steinberg Diagnostic Medical Imaging Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult Cancer Patients, 40 years or older, scheduled for a standard-of-care PET/CT scan.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use	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.	3 months

Collaborators and Investigators

• Sponsor: Canon Medical Systems, USA

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2019
• Primary Completion (ACTUAL): November 26, 2019
• Study Completion (ACTUAL): November 26, 2019

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (ACTUAL): July 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PCD-1000A

Drug and device information, study documents

• 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