18F-FLT Positron Emission Tomography and Diffusion-Weighted Magnetic Resonance Imaging in Planning Surgery and Radiation Therapy and Measuring Response in Patients With Newly Diagnosed Ewing Sarcoma
NCT ID: NCT01825902
Last Updated: 2017-11-20
Study Results
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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COMPLETED
EARLY_PHASE1
1 participants
INTERVENTIONAL
2013-03-31
2015-11-23
Brief Summary
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Detailed Description
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I. Establish correlation between 18F-FLT positron emission tomography (PET) activity, apparent diffusion coefficients (ADC) values from diffusion-weighted magnetic resonance imaging (DW-MRI), fludeoxyglucose F 18 (18F-FDG) PET activity, magnetic resonance imaging (MRI) contrast enhancement, and pathologic response for Ewing sarcoma.
II. Assess the efficacy of detecting therapy induced changes in 18F-FLT PET uptake and ADC from DW-MRI for more accurately predicting local control, event-free survival, and overall survival as compared to standard prognostic factors (e.g. change in tumor size).
III. Compare radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI information to delineation with pre-chemotherapy conventional MRI to determine role of advanced imaging in radiotherapy treatment planning for Ewing sarcoma.
SECONDARY OBJECTIVES:
I. Establish correlation between 18F-FLT PET activity, ADC values from DW-MRI, 18F-FDG PET activity, MRI contrast enhancement, and biomolecular assays for Ewing sarcoma.
II. Determine imaging thresholds to discriminate between viable and necrotic tumor, as established through pathologic correlations.
III. Assess efficacy of advanced imaging for more accurately guiding biopsy targeting by comparing planned targeting with standard (MRI contrast enhancement) vs. advanced imaging (18F -FLT PET and DW-MRI).
IV. Compare post-treatment response assessment with 18F-FLT PET and DW-MRI vs. 18F-FDG PET to determine whether 18F-FLT PET and ADC information is more accurate than 18F-FDG PET for distinguishing between necrosis and non-specific inflammation immediately following treatment.
V. Estimate potential reduction in acute and late side effects based on modified radiation therapy (RT) treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI information as compared to volumes delineated with pre-chemotherapy conventional MRI.
VI. Evaluate automatic image segmentation techniques for 18F-FLT PET and DW-MRI, comparing against biopsy determined imaging thresholds and expert Nuclear Medicine and MR Radiologist contours.
OUTLINE:
Patients undergo 18F-FLT PET, 18F-FDG PET, and DW-MRI the week prior to induction therapy, within one week after the completion of induction therapy, the week prior to RT (for patients that received surgery), and within 1 week of completion of RT.
After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 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, 18F-FDG PET, DW-MRI)
Patients undergo 18F-FLT PET, 18F-FDGPET, and DW-MRI the week prior to induction therapy, within one week after the completion of induction therapy, the week prior to RT (for patients that received surgery), and within 1 week of completion of RT.
fluorine F 18 fluorothymidine
Undergo 18F-FLT PET
fludeoxyglucose F 18
Undergo 18F-FDG PET
positron emission tomography
Undergo 18F-FLT PET and 18F-FDG PET
diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
laboratory biomarker analysis
Correlative studies
Interventions
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fluorine F 18 fluorothymidine
Undergo 18F-FLT PET
fludeoxyglucose F 18
Undergo 18F-FDG PET
positron emission tomography
Undergo 18F-FLT PET and 18F-FDG PET
diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning to receive definitive RT or surgery with or without adjuvant RT
* Willing to sign release of information for any follow-up records
* Provide informed written consent if \>= 18 years; if \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent
* Patients must have measurable disease
* Willingness to participate in mandatory imaging studies
* Willingness to provide mandatory pathology samples for correlative research
Exclusion Criteria
* Unable to undergo 18F-FLT PET scan
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
7 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Nadia N. Laack, M.D.
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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NCI-2013-00707
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1279
Identifier Type: -
Identifier Source: org_study_id