DTPI FDG-PET: Radionecrosis and FDG PET

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT02391246

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma	Other: Positron Emission Tomography Imaging

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

62 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Positron Emission Tomography Imaging Dual time point imaging with 250 MBq of 18F-Fluorodeoxyglucose (18F-FDG)	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.

Arm

Intervention/Treatment

Positron Emission Tomography Imaging

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

Principal Investigator: Lionel S Zuckier, MD, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lionel Zuckier, Principal Investigator, Ottawa Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT02391246

Other Study ID Numbers:

20150094-01H

First Posted:

Mar 18, 2015

Last Update Posted:

Aug 28, 2019

Last Verified:

Aug 1, 2019

Keywords provided by Lionel Zuckier, Principal Investigator, Ottawa Hospital Research Institute

central nervous system tumours

[18F]-fluorodeoxyglucose

Additional relevant MeSH terms:

Glioma

Study Results

No Results Posted as of Aug 28, 2019