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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04024748
Other study ID # PCD-1000A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2019
Est. completion date November 26, 2019

Study information

Verified date July 2019
Source Canon Medical Systems, USA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain. - Define and confirm all supported clinical protocols - Evaluate performance


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 26, 2019
Est. primary completion date November 26, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Steinberg Diagnostic Medical Imaging Centers Henderson Nevada

Sponsors (1)

Lead Sponsor Collaborator
Canon Medical Systems, USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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