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Radionecrosis and FDG PET (DTPI FDG-PET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02391246
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Lionel Zuckier, 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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : June 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. sensitivity and specificity percentages [ Time Frame: 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 :
  1. Cost efficiency analysis [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02391246

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Contact: Marlie Poirier, BScN 613-761-5103

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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Ioana D Moldovan, MD Msc    613-798-5555 ext 18574   
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         
Sponsors and Collaborators
Ottawa Hospital Research Institute
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Principal Investigator: Lionel S Zuckier, MD The Ottawa Hospital
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Responsible Party: Lionel Zuckier, Principal Investigator, Ottawa Hospital Research Institute Identifier: NCT02391246    
Other Study ID Numbers: 20150094-01H
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Lionel Zuckier, Ottawa Hospital Research Institute:
central nervous system tumours
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue