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Brain Imaging Biomarkers for Brain Metastases

Phase 2

Recruiting

Led By Catherine Coolens, Ph. D

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one index lesion with diameter > 1cm and without imaging evidence of hemorrhage

Patients planned for RT to brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years.

Awards & highlights

Study Summary

This trial is testing whether biomarkers can predict how well patients with brain metastases will respond to radiation therapy.

Who is the study for?

This trial is for adults over 18 with confirmed primary cancer and brain metastases visible on scans, who are scheduled for radiation therapy. They must have at least one lesion larger than 1cm without bleeding in the brain and be able to consent. Those with prior whole-brain radiotherapy or radiosurgery to the target lesion, or unable to have contrasted MRI cannot join.Check my eligibility

What is being tested?

The study tests if CT and MRI scans before and after radiation can act as biomarkers—signs that show how severe a disease is or if it's present—to predict treatment response in patients with brain tumors from metastasized cancer.See study design

What are the potential side effects?

There are generally no direct side effects from undergoing CT or MRI scans themselves; however, some individuals may experience discomfort from lying still during the scan or reactions to contrast agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor larger than 1cm without any bleeding inside it.

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I am scheduled for radiation therapy for brain cancer spread.

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I am older than 18 years.

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My cancer diagnosis was confirmed with a biopsy, and I have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) to validate biomarkers

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

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

Secondary outcome measures

Brain Progression Free Survival

Objective (Radiological) Progression

Objective (Radiological) Response

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CT and MRI ScansExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,090 Total Patients Enrolled

Catherine Coolens, Ph. DPrincipal InvestigatorPrincess Margaret Cancer Center - UHN

Media Library

CT and MRI Scans Clinical Trial Eligibility Overview. Trial Name: NCT04197297 — Phase 2

Brain Metastases Research Study Groups: CT and MRI Scans

Brain Metastases Clinical Trial 2023: CT and MRI Scans Highlights & Side Effects. Trial Name: NCT04197297 — Phase 2

CT and MRI Scans 2023 Treatment Timeline for Medical Study. Trial Name: NCT04197297 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this study attempting to fulfill?

"This clinical trial will evaluate the Progression Free Survival (PFS) rate of participants over a 2 year period, which is its primary outcome. Secondary outcomes include Objective Response - defined as stability or reduction in contrast uptake on MRI scans, Radiological Progression – measured by an increase in volume of > 25% compared to prior measurements, and Time to Intracranial Local Progression – determined from initial treatment date until progression noted on imaging studies."

Answered by AI

Is there still an opportunity to enroll in this research protocol?

"The available clinicaltrials.gov data suggests that this research study is presently welcoming applicants. This project was first publicised on October 5th 2021 and has been updated most recently on October 6th 2022."

Answered by AI

Is this treatment conducive to patient safety?

"This therapy has been proven to be safe, therefore it is assigned a score of 2. Evidence suggests that the efficacy may not yet have been assessed in this Phase 2 trial."

Answered by AI

What is the maximum number of participants accepted into this medical experiment?

"Indeed, the data hosted on clinicaltrials.gov reveals that this experiment is still recruiting individuals. It initially appeared on October 5th 2021 and was most recently updated a year after that date. Approximately 90 patients need to be recruited from one of its sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Imaging Biomarkers in Patients With Brain Metastasis

2021. "Brain Imaging Biomarkers in Patients With Brain Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197297.