Clinical trial NCT02822365: Pocket Phantom Tool in Improving Accuracy of Quantitative PET/CT Imaging of Patients With Solid Tumors
Official title: Calibrated Methods for Quantitative PET/CT Imaging Phase II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Solid Neoplasm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-04
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid tumors receiving clinically indicated PET/CT scans.

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.

Detailed description: PRIMARY OBJECTIVES:

I. Optimize the pocket phantom source design and the bias estimation algorithm: determine the tolerances and variations in the source sphere geometry and radioactive filing process; evaluate the need for higher-activity sources in the presence of increased attenuation (i.e. thicker patients); optimize CT contrast levels for source boundary detection and localization from CT images; evaluate the robustness for use with different scanner parameters (e.g. CT slice thicknesses); modify bias estimation algorithm as needed to take into account changes.

II. Develop automated and robust ID pocket phantom processing and web-based software as a service (SAS) analysis tools: automate initial identification of approximate location of the pocket phantom; add automated DICOM analysis for web-based SAS analysis tools for imaging sites.

III. Conduct phantom studies at multiple imaging centers to evaluate the performance with different imaging protocols, scanners, and reconstruction methods. Also test at multiple time points over 6-9 months to assess longitudinal stability.

IV. Conduct a comparative study with patients (at University of Washington \[UW\]) at multiple time points over 6-12 months to evaluate the performance of the pocket phantom in oncology patient imaging compared with current clinical practice.

OUTLINE:

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 CT scan for attenuation correction (CTAC).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patient is pregnant
* Patient cannot or does not provide consent

Primary outcomes:
measure: Difference in measured versus known quantitative values of the pocket phantom
timeFrame: At day 1 (All data will be collected during the clinically scheduled appointment. Analysis will follow typical image reconstruction times.)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Paul Kinahan
role: PRINCIPAL_INVESTIGATOR
References: