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NCT05358340 Clinical Trial

Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions

Brain Tumor Clinical Trial

Official title:
Combined Spin- and Gradient-Echo Perfusion Weighted Imaging for Characterizing Vascular Architecture of Brain Lesions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05358340
Other study ID # 20-6282
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 24, 2021
Est. completion date August 2024

Study information
Verified date May 2023
Source University Health Network, Toronto
Contact Angelica Manalac
Phone 4166035800
Email dual.perfusion@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
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