C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is designed to investigate the effectiveness of Carbon Acetate PET/CT (AC PET)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors. Eligible patients with biopsy proven high grade gliomas (WHO grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ECOG/Zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy. Responders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). Non-responders (those who do not respond clinically, radiographically, or both) will be referred for an FDG PET/CT and initial AC PET/CT within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of AC PET/CT. Specific Goals/Questions: What is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population? How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET) and with that of MRI? Evaluate the optimal timing for post injection imaging.

Official Title
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Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression

Conditions
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Gliomas

Intervention / Treatment
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* Drug: Sodium Acetate C11 PET/CT Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Acetate C11 PET/CT Imaging<br> | Drug: Sodium Acetate C11 PET/CT Imaging<br> <br> * Other names: PET Imaging with Acetate C11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy Correlation | AC PET imaging results will be correlated with tissue biopsy results | 3 weeks from AC PET Imaging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioblastoma, high grade brain tumors, recurrent, pseudo-progression, radionecrosis, carbon acetate, C11 aceate, PET, positron emission tomography