Clinical trial · Interventional
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
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
NCT01825902CI-TRIAL-00030430completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) | Adult Supratentorial Embryonal Tumor, Not Otherwise Specified | ALIAS | 0.85 |
| Ewing Sarcoma of Bone | Bone Ewing Sarcoma | ALIAS | 0.90 |
| Extraosseous Ewing Sarcoma | Extraskeletal Ewing Sarcoma | ALIAS | 0.90 |
| Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | CURATED_BROADER | 0.78 |
| Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | CURATED_BROADER | 0.78 |
| Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor | Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| fluorine F 18 fluorothymidine | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI)
- description
- 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.
- interventionNames
- Drug: fluorine F 18 fluorothymidine
- Radiation: fludeoxyglucose F 18
- Procedure: positron emission tomography
- Procedure: diffusion-weighted magnetic resonance imaging
- Other: laboratory biomarker analysis
Primary outcomes (7)
- measure
- 18F-FLT PET activity
- timeFrame
- At the time of surgical resection
- description
- The primary measure of the samples will be % of viable malignant cells remaining. To examine the correlation of 18F-FLT PET, 18F-FDG PET, and ADC signals in areas of concordance and discordance with standard MR imaging as it impacts differentiation of viable and necrotic tumor extent, sensitivity/specificity and positive/negative predictive values will be estimated. Findings will be summarized using point-estimates and corresponding 95% confidence intervals as appropriate. Differences in sensitivity and specificity will be evaluated using McNemar's test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.