Pocket Phantom Tool in Improving Accuracy of Quantitative PET/CT Imaging of Patients With Solid Tumors
Calibrated Methods for Quantitative PET/CT Imaging Phase II
4 other identifiers
observational
2
1 country
1
Brief Summary
This pilot study tests the pocket phantom tool in improving the accuracy of quantitative positron emission tomography/computed tomography (PET/CT) imaging of patients with solid tumors. The pocket phantom tool may help test the accuracy of the PET/CT scanner and indicate whether adjustments need to be made to get consistent information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedStudy Start
First participant enrolled
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedSeptember 25, 2019
September 1, 2019
3 years
June 22, 2016
September 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in measured versus known quantitative values of the pocket phantom
Compare measured activity of the pocket phantom (as measured by a PET/CT scanner) to the known values of the pocket phantom (as calculated based on half-life activity of known source) to determine accuracy and precision of scanner calibration. This will be used to validate quantitative clinical measurements, like SUV (standardized uptake values), of known solid tumors.
At day 1 (All data will be collected during the clinically scheduled appointment. Analysis will follow typical image reconstruction times.)
Study Arms (1)
Diagnostic (PET/CT)
Patients undergo a PET/CT scan as part of their standard clinical care. While still positioned for the clinical scan, patients undergo additional research PET/CT scans in a smaller region over 10 minutes with the pocket phantom placed nearby and a low-dose single bed position CTAC.
Interventions
Undergo PET/CT scan as clinically indicated (Note: CT is for attenuation correction and not for diagnostic purposes).
Undergo limited field of view PET scan with the Pocket Phantom placed nearby to assist in scanner calibration. No additional PET tracer will be used.
Undergo PET/CT scan as clinically indicated.
Eligibility Criteria
Patients with solid tumors receiving clinically indicated PET/CT scans.
You may qualify if:
- Patient receiving clinically indicated PET/CT scan
- Patient has a known solid tumor
- Patient provides consent
- Patient can tolerate additional time in scanner (i.e. not claustrophobic)
You may not qualify if:
- Patient is pregnant
- Patient cannot or does not provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Kinahan
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 4, 2016
Study Start
August 24, 2016
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
September 25, 2019
Record last verified: 2019-09