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

NCT01961934 | Withdrawn Phase 2

• 1 other identifier: AMIC-AC-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gliomas

Keywords

glioblastoma; high grade brain tumors; recurrent; pseudo-progression; radionecrosis; carbon acetate; C11 aceate; PET; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Biopsy Correlation

  AC PET imaging results will be correlated with tissue biopsy results

  3 weeks from AC PET Imaging

Secondary Outcomes (1)

• SUV (Standardized Uptake Value)

  Day 1 - Assess at time of PET imaging

Study Arms (1)

Sodium Acetate C11 PET/CT Imaging

EXPERIMENTAL

Drug: Sodium Acetate C11 PET/CT Imaging

Interventions

Sodium Acetate C11 PET/CT Imaging DRUG

Also known as: Carbon 11 Acetate, C11 Acetate, AC-PET, PET Imaging with Acetate C11

Sodium Acetate C11 PET/CT Imaging

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 18 years
• Claustrophobic patients

Sponsors & Collaborators

• Phoenix Molecular Imaging: lead

Study Sites (1)

Phoenix Molecular Imaging

Phoenix, Arizona, 85040, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Recurrence

Interventions

Carbon-11; carbon-11 acetate; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Fabio Almeida, MD

  Medical Director, Phoenix Molecular Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director/PI

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 14, 2013
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2018
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)