Clinical trial · Interventional
Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)
Pilot Study to Determine the Utility of [18F] 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma
NCT01308905CI-TRIAL-00026818unknownN/AClinicalTrials.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)
The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.
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 |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLT-PET | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLT-PET
- description
- Patients will be managed per COG protocol ANBL00B1 (low risk, LR), ANBL0521 (intermediate risk, IR), ANBL0531 (high risk, HR) or other future neuroblastoma studies according to their risk group (risk assignment, treatment schema and protocols are available in COG website). The following is a brief description of the treatment. 1. Low risk patients: observation only. 2. Intermediate risk patients: chemotherapy stratified according to risk sub-groups followed by surgical resection. 3. High risk patients: 6 courses of induction chemotherapy, surgical resection and high dose chemotherapy with autologous stem cell transplant (SCT), involved field radiation and 6 months of Isotrenitoin. PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).
- interventionNames
- Device: FLT-PET
Primary outcomes (1)
- measure
- To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
- timeFrame
- 1st PET - At diagnosis
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with neuroblastoma or suspected neuroblastoma seen at Children's Hospital of Michigan (CHM). Patients need to be 2 years or older to be eligible for the initial study * Patients must be 1 day to 21 years old, there is no gender limit. * Diagnosis: All patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for Objective 1. To be eligible for Objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery * Female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant * Patients must be able to lie still for the tests, or have no contraindication for sedation * Patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study * A total number of 40-50 patients will be included in the study Exclusion Criteria: * Patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study * Patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the Objective 1 but excluded for Objective 2.
References
Publications (0)
Data not yet available
No reference posted for this study.