NCT02822365

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 24, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

June 22, 2016

Last Update Submit

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.

Procedure: Computed TomographyDevice: Imaging PhantomsProcedure: Positron Emission Tomography

Interventions

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

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Diagnostic (PET/CT)

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.

Also known as: Phantoms
Diagnostic (PET/CT)

Undergo PET/CT scan as clinically indicated.

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (PET/CT)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Phantoms, ImagingMagnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Equipment and SuppliesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Paul Kinahan

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

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

Locations