Clinical trial · Interventional
Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
NCT03905538CI-TRIAL-00074606withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
The experimental \[18F\]FLT-PET/CT will be completed before initiation of chemotherapy at either diagnosis or initiation of salvage chemotherapy at relapse and prior to the third cycle (or month) of chemotherapy. Laboratory analysis and correlative radiology, as directed per clinical care based on the primary diagnosis, are required within 30 days of the baseline \[18F\]FLT PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]FLT-PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]FLT-PET/CT Arm
- description
- The experimental \[18F\]FLT-PET/CT will be completed before initiation of chemotherapy and prior to the third cycle (or month) of chemotherapy. Laboratory analysis and correlative radiology, as directed per clinical care based on the primary diagnosis, are required within 30 days of the baseline \[18F\]FLT PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
- interventionNames
- Drug: [18F]FLT-PET/CT
Primary outcomes (1)
- measure
- Correlation between change in [18F]FLT PET/CT and progression free and overall survival
- timeFrame
- up to 24 months following treatment
- description
- Determine that a positive response (decrease in quantitative parameters) at an interim \[18F\]FLT PET/CT is related to progression free survival and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed solid tumor malignancies with residual tumors present that require standard of care chemotherapy for a minimum number of cycles. All anatomical sites and all tumor histologies are eligible including central nervous system tumors. Both newly diagnosed and/or newly relapsed patients are eligible. * Patients ages 8 - 25 years * In the opinion of the investigator, patients must be thought to be able to lie still for imaging without sedation for 20 - 30 minutes. * Patients must have a performance status of \> 50% (Lansky or Karnofsky). * Patients of childbearing potential must have a negative urine or serum pregnancy test as per institution's standard of care within 7 days prior to \[18F\]FLT PET/CT imaging. * Ability to understand and the willingness to sign a written informed consent/assent. Exclusion Criteria: * Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to \[18F\]FLT * Newly diagnosed subjects who had prior chemotherapy or radiotherapy before enrollment in the study. Relapsed patients are eligible prior to starting their relapsed chemotherapy regimen if they meet the other eligibility criteria. * Subjects for whom chemotherapy is not a standard of care primary therapy option. * Patients who are pregnant or breast-feeding. * Patients with no residual tumor (i.e. complete resection at diagnosis or relapse).
References
Publications (0)
Data not yet available
No reference posted for this study.