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NCT Number: NCT02822365

Pocket Phantom Tool in Improving Accuracy of Quantitative PET/CT Imaging of Patients With Solid Tumors

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.

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Key information

Conditions

Adult Solid Neoplasm

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT scan as clinically indicated (Note: CT is for attenuation correction and not for diagnostic purposes).

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Imaging Phantoms

Device

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.

Other names: Phantoms

Positron Emission Tomography

Procedure

Undergo PET/CT scan as clinically indicated.

Other names: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Difference in measured versus known quantitative values of the pocket phantom

    Time frame: At day 1 (All data will be collected during the clinically scheduled appointment. Analysis will follow typical image reconstruction times.)

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Calibrated Methods for Quantitative PET/CT Imaging Phase II

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 4, 2016
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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