Brain Imaging Biomarkers in Patients With Brain Metastasis

Brain Metastases, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197297
• Other study ID #: 18-5380
• Status: Recruiting
• Phase: Phase 2
• Start date: October 5, 2021
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: David Shultz, M.D., Ph. D
• Phone: 416-946-6899
• Email: david.shultz[@]rmp.uhn.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Assessment in Neuro-Oncology (RANO) to validate biomarkers	Using RANO to validate imaging predictive biomarkers of response to radiotherapy	Up to 2 years.
Primary	Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers	Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy	Up to 2 years.
Primary	Progression Free Survival (PFS) to validate biomarkers	Using PFS to validate imaging predictive biomarkers of response to radiotherapy	Up to 2 years.
Secondary	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.	Up to 2 years.
Secondary	Objective (Radiological) Response	Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).	Up to 2 years.
Secondary	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.	Up to 2 years.
Secondary	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.	Up to 2 years.
Secondary	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.	Up to 2 years.
Secondary	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.	Up to 2 years.