NCT04197297

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Oct 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2021Jun 2027

First Submitted

Initial submission to the registry

November 25, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

November 25, 2019

Last Update Submit

March 3, 2026

Conditions

Brain Metastases, Adult

Keywords

Radiation TherapyRadiotherapyBiomarkersMagnetic Resonance ImagingComputed TomographyRadiosurgery

Outcome Measures

Primary Outcomes (3)

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

    Using RANO to validate imaging predictive biomarkers of response to radiotherapy

    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

    Up to 2 years.

  • Progression Free Survival (PFS) to validate biomarkers

    Using PFS to validate imaging predictive biomarkers of response to radiotherapy

    Up to 2 years.

Secondary Outcomes (6)

  • Objective (Radiological) Progression

    Up to 2 years.

  • Objective (Radiological) Response

    Up to 2 years.

  • Time to Intracranial Local Progression

    Up to 2 years.

  • Time to Intracranial Distant Progression

    Up to 2 years.

  • Brain Progression Free Survival

    Up to 2 years.

  • +1 more secondary outcomes

Study Arms (1)

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.

Diagnostic Test: CT and MRI Scans

Interventions

CT and MRI ScansDIAGNOSTIC_TEST

CT and MRI scans will occur before and after radiation therapy.

CT and MRI Scans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous Whole Brain Radiotherapy
  • Previous radiosurgery to the index lesion
  • Individuals unable to undergo contrasted MRI for whatever reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, L4W4C2, Canada

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Catherine Coolens, Ph. D

    Princess Margaret Cancer Center - UHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Shultz, M.D., Ph. D

CONTACT

416-946-6899david.shultz@rmp.uhn.on.ca

Catherine Coolens, Ph. D

CONTACT

416-946-5011catherine.coolens@rmp.uhn.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Participants will undergo CT and MRIs before and after radiation therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 13, 2019

Study Start

October 5, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

CA(1)