Verification of Imaging System PCD-1000A

NCT04024748 | Completed FDA Device

• 1 other identifier: PCD-1000A
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

• Define and confirm all supported clinical protocols
• Evaluate performance

Conditions

Cancer Patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Patients already scheduled for a FDG test

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Canon Medical Systems, USA: lead

Study Sites (1)

Steinberg Diagnostic Medical Imaging Centers

Henderson, Nevada, 89052, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: October 22, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: August 6, 2021

Record last verified: 2019-07

Locations

US (1)