NCT05358340

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

April 26, 2022

Last Update Submit

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)

EXPERIMENTAL
Diagnostic Test: Dynamic susceptibility contrast magnetic resonance imaging (DSC MRI)

Interventions

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.

Diagnostic (DSC MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Perfusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Paula Alcaide-Leon, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica Manalac

CONTACT

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

Locations