Radionecrosis and FDG PET (DTPI FDG-PET)
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|ClinicalTrials.gov Identifier: NCT02391246|
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment|
|Malignant Glioma||Other: Positron Emission Tomography Imaging|
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|
|Estimated Enrollment :||62 participants|
|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|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02391246
|Contact: Marlie Poirier, BScNfirstname.lastname@example.org|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Ioana D Moldovan, MD Msc 613-798-5555 ext 18574 email@example.com|
|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|
|Principal Investigator:||Lionel S Zuckier, MD||The Ottawa Hospital|