Recruiting

Radionecrosis

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02391246

Conditions

Malignant Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positron Emission Tomography Imaging

Study Details

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.

Conditions

Malignant Glioma

Study ID

NCT02391246

Start date

Jun, 2015

Status verified date

Aug, 2019

Completion date

Mar, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

62 participants

Anticipated

Interventions and Outcome Measures

Arms

Positron Emission Tomography Imaging

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

Interventions

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 measure

  • sensitivity and specificity percentages [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Marlie Poirier, BScN

613-761-5103mpoirier@ottawaheart.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Ioana D Moldovan, MD Msc

613-798-5555imoldovan@ohri.ca

Principal Investigator:

Lionel S Zuckier, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Keywords

  • central nervous system tumours
  • [18F]-fluorodeoxyglucose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2019-08-28.