NCT01961934

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Phoenix Molecular Imaging · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. 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? 2. 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? 3. Evaluate the optimal timing for post injection imaging.

Conditions

• Gliomas

Interventions

Type	Name	Description
DRUG	Sodium Acetate C11 PET/CT Imaging

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2018-05-01
• First posted: 2013-10-14
• Last updated: 2016-09-28

Locations

1 site across 1 country: United States