C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
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|ClinicalTrials.gov Identifier: NCT01961934|
Recruitment Status : Withdrawn (Awaiting funding)
First Posted : October 14, 2013
Last Update Posted : September 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gliomas||Drug: Sodium Acetate C11 PET/CT Imaging||Phase 2 Phase 3|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2018|
|Experimental: Sodium Acetate C11 PET/CT Imaging||
Drug: Sodium Acetate C11 PET/CT Imaging
- Biopsy Correlation [ Time Frame: 3 weeks from AC PET Imaging ]AC PET imaging results will be correlated with tissue biopsy results
- SUV (Standardized Uptake Value) [ Time Frame: Day 1 - Assess at time of PET imaging ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961934
|United States, Arizona|
|Phoenix Molecular Imaging|
|Phoenix, Arizona, United States, 85040|
|Principal Investigator:||Fabio Almeida, MD||Medical Director, Phoenix Molecular Imaging|