Radionecrosis and FDG PET

• Conditions: Malignant Glioma
• Interventions: Other: Positron Emission Tomography Imaging

• Registration Number: NCT02391246
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

Gliomas are the most common malignant primary central nervous system (CNS) tumours. When high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional sequences is required.The Positron Emission Tomography (PET) radiotracer \[18F\]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.

Detailed Description

Molecular imaging has been used to distinguish recurrent tumor from post-treatment changes through the use of positron emission tomography (PET) as well as other techniques. The best-studied PET radiotracer for this application is \[18F\]-fluorodeoxyglucose (FDG). Normal brain matter is very FDG-avid, making it more difficult to identify lesions and in addition, inflammation associated with radiation injury has been shown to be FDG avid.

In light of this, variations of the standard FDG protocols have been proposed in order to increase overall accuracy, including dual time point imaging (DTPI), consisting of injecting the patient with the standard radiotracer and acquiring two sets of images several hours apart, typically the normal initial images in addition to a delayed acquisition set.

There is good reason to suspect that DTPI FDG-PET would be useful a technique for characterizing lesions in the brain. It's been shown that FDG uptake by normal brain parenchyma initially increases then decreases with time, while tumor uptake typically increases and then plateaus. This pattern of increasing and then decreasing FDG activity has also been seen in inflammatory tissue. The difference in FDG uptake at different times is what allows for a better distinction between malignant and benign tissue.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Study Start: 2015-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Age ≥ 18 years old
• Able and willing to comply with the study procedures
• The patient must be followed at The Ottawa Hospital for a tissue-proven, grade III or IV glioma.
• The patient must have been treated in the past with radiotherapy for glioma.
• A disease recurrence is suspected based on clinical symptoms and/or imaging results.

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Exclusion Criteria

• Missing information regarding tumor type and grade
• Brain biopsy in the ten days preceding DTPI FDG-PET
• Breastfeeding or pregnancy
• Claustrophobia or inability to lie still in a supine position
• Unwillingness or inability to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positron Emission Tomography Imaging	Positron Emission Tomography Imaging	Dual time point imaging with 250 MBq of 18F-Fluorodeoxyglucose (18F-FDG)

Primary Outcome Measures

Name	Time	Method
sensitivity and specificity percentages	3 years	The sensitivity and specificity of dual time point imaging (DTPI) FDG-PET/CT will be compared to the sensitivity and specificity of MR imaging obtained as standard of care for identifying glioma recurrence post-treatment.

Secondary Outcome Measures

Name	Time	Method
Cost efficiency analysis	3 years	At the conclusion of the trial, a cost-efficiency analysis will be performed in an attempt to determine an optimally accurate and cost-efficient imaging strategy for the diagnosis of glioma recurrence.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada