Clinical trial · Interventional
18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
A Phase 2 Study of 18F FTC 146 PET/CT in Patients With Newly Diagnosed Osteosarcoma
NCT04365660CI-TRIAL-00071351terminatedPhase 2Results postedClinicalTrials.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 with no intent of continuing
Summary
Brief summary (as posted)
The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").
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 |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18-F FTC 146 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18-F-FTC 146 PET/CT
- description
- For PET scans, subjects will receive intravenous injection of 10 mCi 18-F -FTC 146 administered twice with 18-F-FTC 146, once at baseline (pre chemotherapy) and once at final study visit (post chemotherapy).
- interventionNames
- Drug: 18-F FTC 146
Primary outcomes (1)
- measure
- Detection of Tumor Necrosis Post-chemotherapy
- timeFrame
- 12 weeks
- description
- Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. The ability of 18F FTC 146 PET/CT to evaluate treatment effect will be assessed as the percentage of tumor that is assessed as necrotic after the treatment course. The outcome will be reported as the mean percentage of the resected tumor (removed by surgery) that is assessed by histopathology as necrotic, with standard deviation.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with biopsy proven osteosarcoma requiring local surgical intervention. * ECOG ≤ 2 * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Chemotherapy in the past 2 months. * Prior history of allergic reaction to 18F FTC 146. * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.