Status:
COMPLETED
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
Lead Sponsor:
Mayo Clinic
Conditions:
Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
Ewing Sarcoma of Bone
Eligibility:
All Genders
7+ years
Phase:
EARLY_PHASE1
Brief 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 r...
Detailed Description
PRIMARY OBJECTIVES: I. Establish correlation between 18F-FLT positron emission tomography (PET) activity, apparent diffusion coefficients (ADC) values from diffusion-weighted magnetic resonance imagi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01825902
Start Date
March 1 2013
End Date
November 23 2015
Last Update
November 20 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905