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

NCT ID: NCT02822365

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-24

Study Completion Date

2019-08-31

Brief Summary

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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

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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).

Conditions

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Adult Solid Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Computed Tomography

Intervention Type PROCEDURE

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

Imaging Phantoms

Intervention Type 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.

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT scan as clinically indicated.

Interventions

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Computed Tomography

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

Intervention Type PROCEDURE

Imaging Phantoms

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.

Intervention Type DEVICE

Positron Emission Tomography

Undergo PET/CT scan as clinically indicated.

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography Phantoms Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Kinahan

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2016-00747

Identifier Type: REGISTRY

Identifier Source: secondary_id

9592

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R42CA167907

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9592

Identifier Type: -

Identifier Source: org_study_id

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