Clinical trial · Interventional
A Pilot Study of 18F-FLT in Pediatric Patients With Central Nervous System (CNS) Tumors
A Pilot, Non-Therapeutic NeuroImaging Study of 18F-FLT in Pediatric Patients With Newly Diagnosed Central Nervous System Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Large phase II opened to accue same patients
Summary
Brief summary (as posted)
In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain tumors relies on the pathologic evaluation of material obtained at the time of the initial operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade lesions due to their increased glucose metabolism, the high tracer uptake of the normal adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a new imaging agent that has two significant advantages in the imaging of CNS tumors. First, this agent detects cellular proliferation directly, and second, the normal brain does not take up the agent, making a positive area(s) easy to identify. Before embarking on a large pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients, the investigators are proposing a limited patient pilot study to evaluate the biodistribution, dosimetry and specificity of this compound when compared to immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing surgical resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors of the Central Nervous System | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FLT | Drug | — | UNRESOLVED |
| PET Imaging | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FLT
- description
- All subjects will receive 18F-FLT prior to PET imaging.
- interventionNames
- Drug: 18F-FLT
- Radiation: PET Imaging
Primary outcomes (1)
- measure
- To determine the distribution, localization and kinetics of localization of 18F-FLT in pediatric patients with central nervous system tumors
- timeFrame
- Assessed shortly after subjects undergo neuroimaging
Secondary outcomes (1)
- measure
- To correlate the activity of administering 18F-FLT in newly diagnosed pediatric brain tumor patients to standard immunohistochemical markers of cellular activation and MRI imaging
- timeFrame
- Assessed shortly after subjects undergo neuroimaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients with newly diagnosed central nervous system tumors undergoing planned surgical resection within 21 days. * Patients should be \< 21 years of age at the time of diagnosis. * Patients should be capable of achieving imaging without the need for sedation or anesthesia. * Karnofsky Performance Status ≥ 50. For infants, the Lansky play scale ≥ 50% can be substituted. * Patients must not be pregnant or nursing. * Signed Informed Consent. * Patients receiving steroids and/or anti-seizure medications are eligible for this study. Exclusion Criteria: * Prior radiation therapy and/or chemotherapy are not permitted. * Active infection * Pregnancy or breast feeding * Serious concurrent medical illness
References
Publications (0)
Data not yet available