Clinical trial · Interventional
C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
NCT01961934CI-TRIAL-00024068withdrawnPhase 2 / Phase 3ClinicalTrials.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): Awaiting funding
Summary
Brief summary (as posted)
This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.
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 |
|---|---|---|---|
| Gliomas | Glioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium Acetate C11 PET/CT Imaging | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sodium Acetate C11 PET/CT Imaging
- interventionNames
- Drug: Sodium Acetate C11 PET/CT Imaging
Primary outcomes (1)
- measure
- Biopsy Correlation
- timeFrame
- 3 weeks from AC PET Imaging
- description
- AC PET imaging results will be correlated with tissue biopsy results
Secondary outcomes (1)
- measure
- SUV (Standardized Uptake Value)
- timeFrame
- Day 1 - Assess at time of PET imaging
- description
- Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest. Comparison of the lesional activity to normal contralateral tracer activity will also be measured.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age 18-70 * Pathologically confirmed World Health Organization (WHO) grade 3 or 4 glioma * ECOG/Zubrod 0-2 * Prior external beam radiotherapy to 59.4-60 Gray by 1.8-2 Gy fractions * Post-radiotherapy contrast-enhanced cranial MRI obtained at least 6 weeks after the completion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis) * Patient completed at least a two week course of palliative steroid therapy for this enhancing anomaly * No prior designated therapy other than steroids for presumed radionecrosis or recurrent tumor * Patient with no clinical and/or radiological response to steroid therapy * Patient eligible for stereotactic brain biopsy * Patient eligible for focal laser therapy Exclusion Criteria: * Patients under the age of 18 years * Claustrophobic patients
References
Publications (0)
Data not yet available
No reference posted for this study.