Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04197297

Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy

Led by University Health Network, Toronto · Updated on 2026-03-05

90

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying patients with brain metastases to see how certain imaging biomarkers can predict responses to radiation treatment. This phase II trial focuses on validating these biomarkers using advanced brain imaging techniques. The study aims to improve understanding of how early changes seen on CT and MRI scans relate to treatment outcomes in these patients. Participants will have CT and MRI scans before starting radiation therapy, and again one week after completing radiotherapy. Another MRI scan will be done during the usual 3-month follow-up visit. These imaging procedures are designed to measure biomarkers that might indicate how well the tumor responds to radiation. Patients will be involved in the study for up to two years, during which time researchers will monitor their scans and clinical status. Outcomes measured include tumor response assessments using established criteria (RANO and RECIST) and progression-free survival. The study also tracks any unexpected or serious side effects related to the treatment over the two-year period.

CONDITIONS

Brief Title

Brain Imaging Biomarkers in Patients With Brain Metastasis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven primary malignancy with brain metastases consistent on imaging
  • At least one brain lesion larger than 1 cm without signs of hemorrhage
  • Age 18 years or older
  • Planned to receive radiation therapy for brain metastases
  • Able to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Previous whole brain radiotherapy
  • Previous radiosurgery to the target brain lesion
  • Unable to undergo contrast-enhanced MRI for any reason

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 2 weeks

Participants undergo CT and MRI scans before and shortly after radiation therapy to measure imaging biomarkers.

2 visits (in-person) within one week before and one week after radiation therapy

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored with an MRI scan during their 3-month post-treatment follow-up as part of routine care, and followed for up to 2 years to assess response and progression.

1 MRI scan at 3 months post-treatment plus other routine follow-up visits over 2 years

Trial Site Locations

Total: 1 location

1

University Health Network

Toronto, Ontario, Canada, L4W4C2

Actively Recruiting

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Research Team

D

David Shultz, M.D., Ph. D

C

Catherine Coolens, Ph. D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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