Overview

This trial is active, not recruiting.

Conditions adult supratentorial primitive neuroectodermal tumor (pnet), ewing sarcoma of bone, extraosseous ewing sarcoma, localized ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic ewing sarcoma/peripheral primitive neuroectodermal tumor, untreated childhood supratentorial primitive neuroectodermal tumor
Treatments fluorine f 18 fluorothymidine, fludeoxyglucose f 18, positron emission tomography, diffusion-weighted magnetic resonance imaging, laboratory biomarker analysis
Sponsor Mayo Clinic
Start date March 2013
End date January 2014
Trial size 9 participants
Trial identifier NCT01825902, MC1279, NCI-2013-00707

Summary

This pilot trial studies fluorine F 18 fluorothymidine (18F-FLT) positron emission tomography and diffusion-weighted magnetic resonance imaging in planing surgery and radiation therapy and measuring response in patients with newly diagnosed Ewing sarcoma. Comparing results of diagnostic procedures done before and after treatment may help doctors predict a patient's response and help plan the best treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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 18F-FLT
Undergo 18F-FLT PET
fludeoxyglucose f 18 18FDG
Undergo 18F-FDG PET
positron emission tomography FDG-PET
Undergo 18F-FLT PET and 18F-FDG PET
diffusion-weighted magnetic resonance imaging diffusion-weighted MRI
Undergo DW-MRI
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
18F-FLT PET activity
time frame: At the time of surgical resection
ADC values from DW-MRI
time frame: At the time of surgical resection
18F-FDG PET activity
time frame: At the time of surgical resection
MRI contrast enhancement
time frame: At the time of surgical resection
Pathologic response
time frame: At the time of surgical resection
18F-FLT PET and DW-MRI in predicting local control, event-free survival, and overall survival, measured by therapy-induced changes in the scans
time frame: Up to 5 years
Radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI
time frame: Up to 5 years

Secondary Outcomes

Measure
Imaging thresholds
time frame: Up to 1 week after completion of chemotherapy and radiation therapy
Efficacy of advanced imaging in accurately guiding biopsy, measured by differences in determining target location by contrast enhancement or 18F-FLT PET and DW-MRI
time frame: At the time of surgery/biopsy
Accuracy in distinguishing between necrosis and non-specific inflammation immediately following treatment
time frame: Up to 5 years
Reduction in acute side effects based on modified RT treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: Within 7 days after completion of RT
Reduction in late side effects based on modified RT treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI as assessed by the NCI CTCAE 4.0 version
time frame: Up to 5 years
Automatic image segmentation techniques for 18F-FLT PET and DW-MRI
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 7 years old.

Inclusion Criteria: - Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing sarcoma (ES) or primitive neuroectodermal tumor (PNET) of bone or soft tissue - 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 MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) - 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

Additional Information

Official title A Pilot Study of the Utility of 18F-FLT-PET and Diffusion-Weighted MRI for Surgical Planning, Radiotherapy Target Delineation, and Treatment Response Evaluation in Ewing Sarcoma Patients
Description PRIMARY OBJECTIVES: 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.