Radionecrosis and FDG PET

NCT ID: NCT02391246

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Malignant Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Positron Emission Tomography Imaging

Dual time point imaging with 250 MBq of 18F-Fluorodeoxyglucose (18F-FDG)

Positron Emission Tomography Imaging

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Lionel Zuckier

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lionel S Zuckier, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Marlie Poirier, BScN

Role: CONTACT

613-761-5103

Facility Contacts

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Ioana D Moldovan, MD Msc

Role: primary

613-798-5555 ext. 18574

Other Identifiers

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20150094-01H

Identifier Type: -

Identifier Source: org_study_id

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