Brain Metastases, AdultPhase 2NCT04197297
Brain Imaging Biomarkers in Patients With Brain Metastasis
A Phase 2 study testing CT and MRI Scans in people with Brain Metastases, Adult, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- CT and MRI Scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2021to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous Whole Brain Radiotherapy
- Previous radiosurgery to the index lesion
- Individuals unable to undergo contrasted MRI for whatever reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, L4W4C2
David Shultz, MD, 416 946 4501, david.shultz@rmp.uhn.ca
About this study
Official title: Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy
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.
Read the detailed description
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.
- Conditions
- Brain Metastases, Adult
- Being tested
- CT and MRI Scans
- Keywords
- Radiation Therapy, Radiotherapy, Biomarkers, Magnetic Resonance Imaging, Computed Tomography, Radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and MRI ScansDiagnostic test
CT and MRI scans will occur before and after radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| CT and MRI Scans | Other | 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. Receives: Diagnostic Test: CT and MRI Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Assessment in Neuro-Oncology (RANO) to validate biomarkers
Using RANO to validate imaging predictive biomarkers of response to radiotherapy
Measured: Up to 2 years.
Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers
Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy
Measured: Up to 2 years.
Progression Free Survival (PFS) to validate biomarkers
Using PFS to validate imaging predictive biomarkers of response to radiotherapy
Measured: Up to 2 years.
Secondary outcomes (6)
Objective (Radiological) Progression
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.
Measured: Up to 2 years.
Objective (Radiological) Response
Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).
Measured: Up to 2 years.
Time to Intracranial Local Progression
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.
Measured: Up to 2 years.
Time to Intracranial Distant Progression
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.
Measured: Up to 2 years.
Brain Progression Free Survival
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.
Measured: Up to 2 years.
Unexpected and/or Serious Toxicities (AEs)
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.
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start5 Oct 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo CT and MRIs before and after radiation therapy.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Coolens, Ph. D, Principal investigator, Princess Margaret Cancer Center - UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197297
- Sponsor's protocol ID
- 18-5380
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT04197297
- Acronym / sponsor ID
- 18-5380
- Conditions
- Brain Metastases, Adult
- Keywords
- Radiation Therapy, Radiotherapy, Biomarkers, Magnetic Resonance Imaging, Computed Tomography, Radiosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo CT and MRIs before and after radiation therapy.
| Arm | Type | Receives |
|---|---|---|
| CT and MRI Scans | Other | Diagnostic Test: CT and MRI ScansEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous Whole Brain Radiotherapy
- Previous radiosurgery to the index lesion
- Individuals unable to undergo contrasted MRI for whatever reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT and MRI ScansCT and MRI scans will occur before and after radiation therapy. | Diagnostic test | CT and MRI Scans |
Primary outcome
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
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
Progression Free Survival (PFS) to validate biomarkers
Time frame: Up to 2 years.
Using PFS to validate imaging predictive biomarkers of response to radiotherapy
6 secondary outcomes
Objective (Radiological) Progression
Time frame: Up to 2 years.
Objective (Radiological) Response
Time frame: Up to 2 years.
Time to Intracranial Local Progression
Time frame: Up to 2 years.
Time to Intracranial Distant Progression
Time frame: Up to 2 years.
Brain Progression Free Survival
Time frame: Up to 2 years.
Unexpected and/or Serious Toxicities (AEs)
Time frame: Up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Coolens, Ph. D principal investigator
Princess Margaret Cancer Center - UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT and MRI Scans in people with Brain Metastases, Adult, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Shultz, M.D., Ph. D (416-946-6899, david.shultz@rmp.uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Assessment in Neuro-Oncology (RANO) to validate biomarkers (time frame: Up to 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.