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

• Status: Withdrawn
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Molecular Imaging

Criteria

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