Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector
This study is currently recruiting participants.
Verified November 2012 by Philips Healthcare
Sponsor:
Philips Healthcare
Collaborators:
University Hospital Case Medical Center
Case Western Reserve University
IMARC Research
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01731860
First received: November 9, 2012
Last updated: November 30, 2012
Last verified: November 2012
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| First Received Date ICMJE | November 9, 2012 | ||||||||
| Last Updated Date | November 30, 2012 | ||||||||
| Start Date ICMJE | November 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Imaging Capabilities and Performance of the Alpha Ring [ Time Frame: Within 1 month of image acquisition ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01731860 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients already scheduled for a clinically necessary PET/CT scan. |
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| Condition ICMJE | Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology. | ||||||||
| Intervention ICMJE | Device: Additional PET Scan
Additional PET Scan with no additional radiopharmaceutical administration. |
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| Study Group/Cohort (s) | Patients receiving PET/CT
Patients already scheduled for a clinically necessary PET/CT scan.
Intervention: Device: Additional PET Scan |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 35 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01731860 | ||||||||
| Other Study ID Numbers ICMJE | Alpha Ring 12-001 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Philips Healthcare | ||||||||
| Study Sponsor ICMJE | Philips Healthcare | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Philips Healthcare | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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