Trials Sponsors Conditions Drugs Pricing

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 imagingDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Canon Medical Systems, USA
Industrylead

Study Sites (1)

Steinberg Diagnostic Medical Imaging Centers

Henderson, Nevada, 89052, United States

Enrollment

24 participants (actual enrollment reported by the registry).

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

Actual (reported)

Verification of Imaging System PCD-1000A

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients already scheduled for a FDG test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients already scheduled for a FDG test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations