Radionecrosis and FDG PET (DTPI FDG-PET)

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Glioma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 62

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Principal Investigator: Lionel S Zuckier, MD
      • Sub-Investigator: Thanh Nguyen, MD
      • Sub-Investigator: Caudrelier Jean-Michel, MD
      • Sub-Investigator: Pham Xuan, MD
      • Sub-Investigator: Alkherayf Fahad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be patients who have previously been treated with radiochemotherapy for high grade gliomas who are clinically assessed with a brain MRI for suspected disease recurrence.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Lionel S Zuckier, MD, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (ESTIMATE): March 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: central nervous system tumours; [18F]-fluorodeoxyglucose
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 20150094-01H