Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using brain imaging to predict treatment response in patients with brain metastases

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

Run by University Health Network, Toronto · NCT04197297 · Data updated 2026-11-12

This study is testing if brain scans can help predict how well patients with brain metastases will respond to radiation treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Drugs / interventionsradiation
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedOctober 5, 2021
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedMarch 5, 2026
Trial IDNCT04197297 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old with biopsy-proven primary malignancies and brain metastases who are planned for radiation treatment.

Probably not a fit

Patients who have previously undergone whole brain radiotherapy or radiosurgery to the index lesion may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on patients with brain metastases who are scheduled to receive radiation treatment. Participants will undergo CT and MRI scans before and after their treatment to measure specific biomarkers that may indicate how well they will respond to the therapy. The goal is to validate the predictive abilities of these imaging biomarkers, which could help tailor treatment plans for better outcomes. Conducted at the Princess Margaret Cancer Center, this single-center phase II study aims to enroll up to 90 patients over a two-year period.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment personalization for patients with brain metastases, enhancing their response to radiation therapy.

How similar studies have gone: Previous studies have suggested that imaging biomarkers can predict treatment response, indicating that this approach has potential based on earlier findings.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
* At least one index lesion with diameter \> 1cm and without imaging evidence of hemorrhage
* Patients age \> 18 years of age
* Patients planned for RT to brain metastases
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Previous Whole Brain Radiotherapy
* Previous radiosurgery to the index lesion
* Individuals unable to undergo contrasted MRI for whatever reason

Where it's running

  • University Health Network
    Toronto, Ontario, Canada
    Recruiting

Study contacts

  • Principal investigator: Catherine Coolens, Ph. D — Princess Margaret Cancer Center - UHN
  • Study coordinator: David Shultz, M.D., Ph. D
  • Email: david.shultz@rmp.uhn.on.ca
  • Phone: 416-946-6899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.