Adult Solid NeoplasmNCT02822365
Pocket Phantom Tool in Improving Accuracy of Quantitative PET/CT Imaging of Patients With Solid Tumors
An observational study of Adult Solid Neoplasm, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Adult Solid Neoplasm
- What is being tested?
- Computed Tomography, Imaging Phantoms and Positron Emission Tomography
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2016to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid tumors receiving clinically indicated PET/CT scans.
Who may be able to join
- 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)
Who cannot join
- Patient is pregnant
- Patient cannot or does not provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Calibrated Methods for Quantitative PET/CT Imaging Phase II
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Adult Solid Neoplasm
- Being tested
- Computed Tomography, Imaging Phantoms, Positron Emission Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT scan as clinically indicated (Note: CT is for attenuation correction and not for diagnostic purposes).
Imaging PhantomsDevice
Also called 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.
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo PET/CT scan as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Device: Imaging Phantoms; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 1 (All data will be collected during the clinically scheduled appointment. Analysis will follow typical image reconstruction times.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start24 Aug 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul Kinahan, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822365
- Sponsor's protocol ID
- 9592
- Other IDs
- NCI-2016-00747, 9592, P30CA015704, R42CA167907
- Status last verified
- Sep 2019
- First submitted
- 22 Jun 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibrated Methods for Quantitative PET/CT Imaging Phase II
- ClinicalTrials.gov ID
- NCT02822365
- Acronym / sponsor ID
- 9592
- Conditions
- Adult Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (PET/CT) | – | Procedure: Computed Tomography, Device: Imaging Phantoms, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors receiving clinically indicated PET/CT scans.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Patient is pregnant
- Patient cannot or does not provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT scan as clinically indicated (Note: CT is for attenuation correction and not for diagnostic purposes). | Procedure or surgery | Diagnostic (PET/CT) |
| Imaging PhantomsAlso: PhantomsUndergo limited field of view PET scan with the Pocket Phantom placed nearby to assist in scanner calibration. No additional PET tracer will be used. | Device | Diagnostic (PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo PET/CT scan as clinically indicated. | Procedure or surgery | Diagnostic (PET/CT) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kinahan principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Solid Neoplasm, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.