Radionecrosis and FDG PET

NCT02391246 | Unknown

• 1 other identifier: 20150094-01H
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

central nervous system tumours; [18F]-fluorodeoxyglucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost efficiency analysis

  3 years

Study Arms (1)

Positron Emission Tomography Imaging

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

Other: Positron Emission Tomography Imaging

Interventions

Positron Emission Tomography Imaging OTHER

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.

Positron Emission Tomography Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lionel S Zuckier, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlie Poirier, BScN

CONTACT

613-761-5103; mpoirier@ottawaheart.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: March 18, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CA (1)