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

Gliomas Clinical Trial

Official title:

Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01961934
• Other study ID #: AMIC-AC-003
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 9, 2013
• Last updated: September 27, 2016
• Start date: May 2014
• Est. completion date: May 2018

Study information

• Verified date: September 2016
• Source: Phoenix Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Disease Progression
• Glioma
• Gliomas
• Necrosis

Intervention

Drug:
• Sodium Acetate C11 PET/CT Imaging

Locations

Country	Name	City	State
United States	Phoenix Molecular Imaging	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy Correlation	AC PET imaging results will be correlated with tissue biopsy results	3 weeks from AC PET Imaging	No
Secondary	SUV (Standardized Uptake Value)	Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest. Comparison of the lesional activity to normal contralateral tracer activity will also be measured.	Day 1 - Assess at time of PET imaging	No