Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT05358340
Collaborator
(none)
100
1
1
34.2
2.9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Combined Spin- and Gradient-Echo Perfusion Weighted Imaging for Characterizing Vascular Architecture of Brain Lesions
Actual Study Start Date
:
Sep 24, 2021
Anticipated Primary Completion Date
:
Aug 1, 2024
Anticipated Study Completion Date
:
Aug 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic (DSC MRI)
|
Diagnostic Test: Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)
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.
|
Outcome Measures
Primary Outcome Measures
- Measurement of perfusion parameter: cerebral blood volume (CBV) [Baseline to end of study (up to 2 years)]
Measurements of cerebral blood volume (CBV) will be calculated.
- Measurement of perfusion parameter: vessel size index (VSI) [Baseline to end of study (up to 2 years)]
Measurements of vessel size index (VSI) will be calculated.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Paula Alcaide-Leon, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT05358340
Other Study ID Numbers:
- 20-6282
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: