Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
Combined Spin- and Gradient-Echo Perfusion Weighted Imaging for Characterizing Vascular Architecture of Brain Lesions
1 other identifier
interventional
100
1 country
1
Brief Summary
The objectives of the study are (1) to evaluate the feasibility of using a combined spin- and gradient- echo (SAGE) sequence in dynamic susceptibility contrast magnetic resonance imaging (DSC MRI) and (2) to determine quantitative estimates of vessel density and size to differentiate between areas of radiation necrosis and tumor recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2021
CompletedFirst Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedMay 9, 2023
May 1, 2023
2.9 years
April 26, 2022
May 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Measurement of perfusion parameter: cerebral blood volume (CBV)
Measurements of cerebral blood volume (CBV) will be calculated.
Baseline to end of study (up to 2 years)
Measurement of perfusion parameter: vessel size index (VSI)
Measurements of vessel size index (VSI) will be calculated.
Baseline to end of study (up to 2 years)
Study Arms (1)
Diagnostic (DSC MRI)
EXPERIMENTALInterventions
A dye, known as a contrast agent, will be injected through a needle that is inserted into a vein in the arm or hand. Subsequent magnetic resonance imaging will follow.
Eligibility Criteria
You may qualify if:
- Diagnosed with a brain metastasis or primary brain tumour and who will undergo MRI with contrast.
You may not qualify if:
- Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
- Subject with documented contrast medium injection contraindication due to severe kidney disease or allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula Alcaide-Leon, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2022
First Posted
May 3, 2022
Study Start
September 24, 2021
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
May 9, 2023
Record last verified: 2023-05