Confirm PCA-9000A PET/CT System is Effective for Its Intended UseNCT01701167
Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain
An observational study of Confirm PCA-9000A PET/CT System is Effective for Its Intended Use, run by Toshiba America Medical Systems, Inc. at 1 site in United States.
Trial summary
The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Confirm PCA-9000A PET/CT System is Effective for Its Intended Use
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2013
- 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
- Adult, Older adult
Study population: Patients already scheduled for a FDG test.
Who may be able to join
- Patients already scheduled for an FDG test at SDMI
- 40 years and older
- Adult must be able to sign an informed consent form
Who cannot join
- Patients not scheduled for an FDG test at SDMI
- 39 years or younger
- Pregnant adult female or plan to be pregnant
- Adult who is unable to sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Steinberg Diagnostic Medical Imaging Centers
Henderson, Nevada, 89052
Jim Kelley, 702-240-1215
Mark L Winkler, M.D.
About this study
Official title: ROMAN (PCA-9000A) PET/CT System Verification
The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.
Read the detailed description
Scope:
To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.
- Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
- Verification of the quantitative accuracy of the imaging chain.
- Evaluate the performance and stability of the new system and its related quality control and calibration procedures.
Result (Expected):
The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Confirm PCA-9000A PET/CT System is Effective for Its Intended UseStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toshiba America Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701167
- Sponsor's protocol ID
- ROMAN-01
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROMAN (PCA-9000A) PET/CT System Verification
- ClinicalTrials.gov ID
- NCT01701167
- Acronym / sponsor ID
- ROMAN-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Toshiba America Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (estimated)
- First posted
- 4 Oct 2012 (estimated)
- 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.
The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.
Detailed description
Scope:
To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.
- Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
- Verification of the quantitative accuracy of the imaging chain.
- Evaluate the performance and stability of the new system and its related quality control and calibration procedures.
Result (Expected):
The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients already scheduled for a FDG test.
Key inclusion criteria (3 listed)
- Patients already scheduled for an FDG test at SDMI
- 40 years and older
- Adult must be able to sign an informed consent form
Key exclusion criteria (4 listed)
- Patients not scheduled for an FDG test at SDMI
- 39 years or younger
- Pregnant adult female or plan to be pregnant
- Adult who is unable to sign the 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.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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.
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 Confirm PCA-9000A PET/CT System is Effective for Its Intended Use, run by Toshiba America Medical Systems, Inc. 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: status not confirmed, as of the sponsor's last update on 4 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 4 Oct 2012.