Back to resultsDual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
Primary Purpose
Brain Tumor, Brain Metastases
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Tumor
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with a brain metastasis or primary brain tumour and who will undergo MRI with contrast.
Exclusion Criteria:
- 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.
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (DSC MRI)
Arm Description
Outcomes
Primary Outcome Measures
Measurement of perfusion parameter: cerebral blood volume (CBV)
Measurements of cerebral blood volume (CBV) will be calculated.
Measurement of perfusion parameter: vessel size index (VSI)
Measurements of vessel size index (VSI) will be calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT05358340
First Posted
April 26, 2022
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05358340
Brief Title
Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
Official Title
Combined Spin- and Gradient-Echo Perfusion Weighted Imaging for Characterizing Vascular Architecture of Brain Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Brain Metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (DSC MRI)
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of perfusion parameter: cerebral blood volume (CBV)
Description
Measurements of cerebral blood volume (CBV) will be calculated.
Time Frame
Baseline to end of study (up to 2 years)
Title
Measurement of perfusion parameter: vessel size index (VSI)
Description
Measurements of vessel size index (VSI) will be calculated.
Time Frame
Baseline to end of study (up to 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with a brain metastasis or primary brain tumour and who will undergo MRI with contrast.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelica Manalac
Phone
4166035800
Ext
3193
Email
dual.perfusion@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Alcaide-Leon, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
We'll reach out to this number within 24 hrs