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CompletedNCT04024748Updated Aug 6, 2021

Verification of Imaging System PCD-1000A

An observational study in Cancer Patients, sponsored by Canon Medical Systems, USA. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Canon Medical Systems, USA · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
24
Ages
40 Years and older
Sex
All
01

Study summary

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

  • Define and confirm all supported clinical protocols
  • Evaluate performance
Read the detailed description

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

02

Conditions studied

  • Cancer Patients
03

In context

Lead sponsor

This is the only study on the registry with Canon Medical Systems, USA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePET/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.

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • Steinberg Diagnostic Medical Imaging Centers
    Henderson, Nevada 89052, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04024748
Lead sponsor
Canon Medical Systems, USA
Responsible party
Sponsor
First posted
Jul 18, 2019
Start date
Oct 22, 2019
Primary completion
Nov 26, 2019
Completion
Nov 26, 2019
Last update
Aug 6, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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