Menu
Recruiting NCT04197297

Brain Imaging Biomarkers in Patients With Brain Metastasis

Phase II Interventional Brain Metastases, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CT and MRI Scans.
Who it may be relevant to
Registry conditions: Brain Metastases, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test CT and MRI Scans
    CT and MRI scans will occur before and after radiation therapy.

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • 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.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT04197297 · 18-5380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗