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NCT Number: NCT04197297

Brain Imaging Biomarkers in Patients With Brain Metastasis

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.

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Key information

Conditions

Brain Metastases, Adult Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network

Toronto, Ontario, L4W4C2, Canada

Location status: Recruiting

Location contact

David Shultz, MD

CONTACT

[email protected]

416 946 4501

About this study

Advances in medical imaging can provide useful information to guide and look at the response to treatment. Previous studies suggest early changes in the tumor after radiation treatment may be detectable using special MRI (Magnetic Resonance Imaging), and CT (Computed Tomography) scans. A biomarker is a measureable indicator of the severity or presence of some disease state. Previous studies suggest that the change in several imaging biomarkers can predict who will respond to radiation treatment. In this study, patients will undergo CT and MRI scans prior to and after radiation treatment to measure these biomarkers. The purpose of this study is to validate the predictive abilities of biomarkers in terms of determining how patients will respond to radiation treatment. This is a single-center phase II study, which will be conducted at the Princess Margaret Cancer Center. The study will be enrolling up to a total of 90 patients who will be receiving radiation treatment for brain metastases. Patients will be asked to participate within this study for 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT and MRI Scans

Diagnostic Test

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

Primary outcomes

  1. Response Assessment in Neuro-Oncology (RANO) to validate biomarkers

    Time frame: Up to 2 years.

    Using RANO to validate imaging predictive biomarkers of response to radiotherapy

  2. Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers

    Time frame: Up to 2 years.

    Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy

  3. Progression Free Survival (PFS) to validate biomarkers

    Time frame: Up to 2 years.

    Using PFS to validate imaging predictive biomarkers of response to radiotherapy

Secondary outcomes

  1. Objective (Radiological) Progression

    Time frame: Up to 2 years.

    Defined as increase in volume of contrast uptake on MRI of > 25% as measured by two perpendicular tumor diameters compared to the smallest measurement ever for the same lesion by the same technique.

  2. Objective (Radiological) Response

    Time frame: Up to 2 years.

    Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).

  3. Time to Intracranial Local Progression

    Time frame: Up to 2 years.

    Defined as the time interval between the date of first treatment and the date of objective radiological progression of any one of the treated lesions.

  4. Time to Intracranial Distant Progression

    Time frame: Up to 2 years.

    Defined as the time interval between the date of first treatment and the date of new brain metastases, with or without progression of the treated lesions.

  5. Brain Progression Free Survival

    Time frame: Up to 2 years.

    Defined as the time interval between the date of first treatment and the date of disease progression in the brain or death due to disease in the brain, whichever comes first.

  6. Unexpected and/or Serious Toxicities (AEs)

    Time frame: Up to 2 years.

    AEs that are deemed by the PI to be possibly, probably or definitely attributable to the research MRI and/or CT will be reported according to CTCAE version 4.3.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Coolens, Ph. D

CONTACT

[email protected]

416-946-5011

David Shultz, M.D., Ph. D

CONTACT

[email protected]

416-946-6899

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2019
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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