Radionecrosis and FDG PET

Malignant Glioma Clinical Trial

— DTPI FDG-PET  

Official title:

A Dual Time Point FDG-PET to Differentiate Between Recurrent Brain Tumor and Radionecrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02391246
• Other study ID #: 20150094-01H
• Status: Recruiting
• Start date: June 2015
• Est. completion date: March 2020

Study information

• Verified date: August 2019
• Source: Ottawa Hospital Research Institute
• Contact: Marlie Poirier, BScN
• Phone: 613-761-5103
• Email: mpoirier[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Other:
• Positron Emission Tomography Imaging
Participants will receive an intravenous injection of 250 MBq (megabecquerels) of 18F-Fluorodeoxyglucose (18F-FDG). The first Positron Emission Tomography (PET) acquisition of the head will occur one hour post-injection. The second acquisition will take place 3 hours post-injection. Both early and late PET images will be manually co-registered with the participant's most recent magnetic resonance images.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity percentages	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.	3 years
Secondary	Cost efficiency analysis	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.	3 years