Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.NCT01731860
Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
A study testing Additional PET Scan in people with Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology., run by Philips Healthcare at 1 site in United States.
Trial summary
A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.
- What is being tested?
- Additional PET Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are at least 18 years
- Patients are medically stable
- Patients scheduled for clinically necessary PET/CT examination
Who cannot join
- Patients who are pregnant
- Patients who are unwilling/unable to sign the Informed Consent Form
- Patients who are cognitively impaired and unable to provide informed consent
- Patients who have experienced adverse events to PET/CT examinations
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product
A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system.
The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.
- Being tested
- Additional PET Scan
- Keywords
- PET/CT, Philips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional PET ScanDevice
Additional PET Scan with no additional radiopharmaceutical administration.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving PET/CT | Experimental | Patients already scheduled for a clinically necessary PET/CT scan. Receives: Device: Additional PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging Capabilities and Performance of the Alpha Ring
Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.
Measured: Within 1 month of image acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center, Case Western Reserve University, Imarc Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter F Faulhaber, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731860
- Sponsor's protocol ID
- Alpha Ring 12-001
- Status last verified
- Sep 2016
- First submitted
- 9 Nov 2012
- Last updated
- 4 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product
- ClinicalTrials.gov ID
- NCT01731860
- Acronym / sponsor ID
- Alpha Ring 12-001
- Keywords
- PET/CT, Philips
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center, Case Western Reserve University, Imarc Research, Inc.
- Study start
- Nov 2012
- Primary completion
- Jul 2016 (actual)
- First posted
- 22 Nov 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.
A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system.
The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving PET/CT | Experimental | Device: Additional PET ScanPatients already scheduled for a clinically necessary PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are at least 18 years
- Patients are medically stable
- Patients scheduled for clinically necessary PET/CT examination
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Patients who are unwilling/unable to sign the Informed Consent Form
- Patients who are cognitively impaired and unable to provide informed consent
- Patients who have experienced adverse events to PET/CT examinations
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 |
|---|---|---|
| Additional PET ScanAdditional PET Scan with no additional radiopharmaceutical administration. | Device | Patients receiving PET/CT |
Primary outcome
Imaging Capabilities and Performance of the Alpha Ring
Time frame: Within 1 month of image acquisition
Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.
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 4 Oct 2016.
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.
Peter F Faulhaber, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional PET Scan in people with Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology., run by Philips Healthcare 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 4 Oct 2016. 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?
Imaging Capabilities and Performance of the Alpha Ring (time frame: Within 1 month of image acquisition). 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 4 Oct 2016.