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

NCT ID: NCT01961934

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sodium Acetate C11 PET/CT Imaging

Group Type: EXPERIMENTAL

Sodium Acetate C11 PET/CT Imaging

Intervention Type: DRUG

Interventions

Sodium Acetate C11 PET/CT Imaging

Intervention Type: DRUG

Other Intervention Names

Carbon 11 Acetate; C11 Acetate; AC-PET; PET Imaging with Acetate C11

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Molecular Imaging

OTHER

Sponsor Role: lead

Responsible Party

Fabio Almeida MD

Medical Director/PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio Almeida, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director, Phoenix Molecular Imaging

Locations

Phoenix Molecular Imaging

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

AMIC-AC-003

Identifier Type: -

Identifier Source: org_study_id