Cancer PatientsNCT04024748
Verification of Imaging System PCD-1000A
An observational study of Cancer Patients, run by Canon Medical Systems, USA at 1 site in United States.
Trial summary
Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain. Define and confirm all supported clinical protocols Evaluate performance Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cancer Patients
- What is being tested?
- PET/CT imaging
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 26 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Cancer Patients, 40 years or older, scheduled for a standard-of-care PET/CT scan.
Who may be able to join
- Patients already scheduled for an FDG test at SDMI
- 40 years and older
- Capable of providing their informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Steinberg Diagnostic Medical Imaging Centers
Henderson, Nevada, 89052
About this study
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.
- Conditions
- Cancer Patients
- Being tested
- PET/CT imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start22 Oct 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canon Medical Systems, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024748
- Sponsor's protocol ID
- PCD-1000A
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Imaging System PCD-1000A
- ClinicalTrials.gov ID
- NCT04024748
- Acronym / sponsor ID
- PCD-1000A
- Conditions
- Cancer Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Canon Medical Systems, USAIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain.
- Define and confirm all supported clinical protocols
- Evaluate performance
Detailed description
The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients already scheduled for a FDG test | – | Device: PET/CT imagingSubjects 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Cancer Patients, 40 years or older, scheduled for a standard-of-care PET/CT scan.
Key inclusion criteria (3 listed)
- Patients already scheduled for an FDG test at SDMI
- 40 years and older
- Capable of providing their informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT imagingSubjects 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. | Device | Patients already scheduled for a FDG test |
Primary outcome
Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients, run by Canon Medical Systems, USA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.