Verification of Imaging System PCD-1000A

Cancer Patients Clinical Trial

Official title:

Verification of Imaging System PCD-1000A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024748
• Other study ID #: PCD-1000A
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cancer Patients

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