18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors
NCT ID: NCT02167204
Last Updated: 2020-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2012-11-30
2019-01-21
Brief Summary
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Detailed Description
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I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).
II. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.
III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).
SECONDARY OBJECTIVES:
I. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor disease burden.
OUTLINE:
Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
After completion of study, patients are followed for up to 7 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (18F-FLT PET/CT)
Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
Computed Tomography
Undergo 18F-FLT PET/CT
Fluorothymidine F-18
Undergo 18F-FLT PET/CT
Positron Emission Tomography
Undergo 18F-FLT PET/CT
Interventions
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Computed Tomography
Undergo 18F-FLT PET/CT
Fluorothymidine F-18
Undergo 18F-FLT PET/CT
Positron Emission Tomography
Undergo 18F-FLT PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined
Exclusion Criteria
* Pregnancy
* Inability to lie still for the imaging study
* Weight over 350 lbs.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Jason Rockhill
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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2013-02162
Identifier Type: REGISTRY
Identifier Source: secondary_id
7754
Identifier Type: OTHER
Identifier Source: secondary_id
7754
Identifier Type: -
Identifier Source: org_study_id
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