Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05358340

Conditions

Brain Tumor

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)

Study Details

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.

Conditions

Brain Tumor

Brain Metastases

Study ID

NCT05358340

Start date

Sep 24, 2021

Status verified date

May, 2023

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (DSC MRI)

Interventions

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.

Primary outcome measure

  • Measurement of perfusion parameter: cerebral blood volume (CBV) [ Time Frame: Baseline to end of study (up to 2 years) ]
  • Measurement of perfusion parameter: vessel size index (VSI) [ Time Frame: Baseline to end of study (up to 2 years) ]

Central Contacts and Locations

Central contacts

Angelica Manalac

4166035800dual.perfusion@gmail.com

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 9, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-05-09.