Recruiting
Phase 2

Biomarkers

Sponsor:

University Health Network, Toronto

Code:

NCT04197297

Conditions

Brain Metastases, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT and MRI Scans

Study Details

Brief summary:

A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.

Conditions

Brain Metastases, Adult

Study ID

NCT04197297

Start date

Oct 5, 2021

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: CT and MRI Scans

Each patient will undergo a 3T MRI scan as well as a dynamic contrast-enhanced CT scan within one week prior to the start of treatment. Patients will also undergo a research 3T MRI scan and research dynamic contrast-enhanced CT scan at the one week post radiotherapy mark. An MRI scan during their 3 month post-treatment follow up visits will take place as per routine standard of care.

Interventions

CT and MRI Scans

CT and MRI scans will occur before and after radiation therapy.

Primary outcome measure

  • Response Assessment in Neuro-Oncology (RANO) to validate biomarkers [ Time Frame: Up to 2 years. ]
  • Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers [ Time Frame: Up to 2 years. ]
  • Progression Free Survival (PFS) to validate biomarkers [ Time Frame: Up to 2 years. ]

Central Contacts and Locations

Central contacts

David Shultz, M.D., Ph. D

416-946-6899david.shultz@rmp.uhn.on.ca

Catherine Coolens, Ph. D

416-946-5011catherine.coolens@rmp.uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, L4W4C2

Contacts

David Shultz, MD

416 946 4501david.shultz@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Radiation Therapy
  • Radiotherapy
  • Biomarkers
  • Magnetic Resonance Imaging
  • Computed Tomography
  • Radiosurgery

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 2026-03-05.