Clinical trial NCT04197297: Brain Imaging Biomarkers in Patients With Brain Metastasis
Official title: Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brain Metastases, Adult
Keywords: Radiation Therapy
Radiotherapy
Biomarkers
Magnetic Resonance Imaging
Computed Tomography
Radiosurgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will undergo CT and MRIs before and after radiation therapy.
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: Response Assessment in Neuro-Oncology (RANO) to validate biomarkers
timeFrame: Up to 2 years.
measure: Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers
timeFrame: Up to 2 years.
measure: Progression Free Survival (PFS) to validate biomarkers
timeFrame: Up to 2 years.
Secondary outcomes:
measure: Objective (Radiological) Progression
timeFrame: Up to 2 years.
measure: Objective (Radiological) Response
timeFrame: Up to 2 years.
measure: Time to Intracranial Local Progression
timeFrame: Up to 2 years.
measure: Time to Intracranial Distant Progression
timeFrame: Up to 2 years.
measure: Brain Progression Free Survival
timeFrame: Up to 2 years.
measure: Unexpected and/or Serious Toxicities (AEs)
timeFrame: Up to 2 years.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Center - UHN
name: Catherine Coolens, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: