Gliomas Clinical Trial
Official title:
Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
Verified date | September 2016 |
Source | Phoenix Molecular Imaging |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2018 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Phoenix Molecular Imaging | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Phoenix Molecular Imaging |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biopsy Correlation | AC PET imaging results will be correlated with tissue biopsy results | 3 weeks from AC PET Imaging | No |
Secondary | SUV (Standardized Uptake Value) | 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. | Day 1 - Assess at time of PET imaging | No |
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