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

Phoenix Molecular Imaging

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Gliomas

Treatments

Drug: Sodium Acetate C11 PET/CT Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01961934

AMIC-AC-003

Details and patient eligibility

About

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.

Full 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:

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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