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Brain Imaging Biomarkers in Patients With Brain Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197297
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Brain Metastases, Adult Diagnostic Test: CT and MRI Scans Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will undergo CT and MRIs before and after radiation therapy.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CT and MRI Scans
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
CT and MRI scans will occur before and after radiation therapy.




Primary Outcome Measures :
  1. Response Assessment in Neuro-Oncology (RANO) to validate biomarkers [ Time Frame: Up to 2 years. ]
    Using RANO to validate imaging predictive biomarkers of response to radiotherapy

  2. Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers [ Time Frame: Up to 2 years. ]
    Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy

  3. Progression Free Survival (PFS) to validate biomarkers [ Time Frame: Up to 2 years. ]
    Using PFS to validate imaging predictive biomarkers of response to radiotherapy


Secondary Outcome Measures :
  1. Objective (Radiological) Progression [ Time Frame: Up to 2 years. ]
    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.

  2. Objective (Radiological) Response [ Time Frame: Up to 2 years. ]
    Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).

  3. Time to Intracranial Local Progression [ Time Frame: Up to 2 years. ]
    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.

  4. Time to Intracranial Distant Progression [ Time Frame: Up to 2 years. ]
    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.

  5. Brain Progression Free Survival [ Time Frame: Up to 2 years. ]
    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.

  6. Unexpected and/or Serious Toxicities (AEs) [ Time Frame: Up to 2 years. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197297


Contacts
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Contact: David Shultz, M.D., Ph. D 416-946-6899 david.shultz@rmp.uhn.on.ca
Contact: Catherine Coolens, Ph. D 416-946-5011 catherine.coolens@rmp.uhn.ca

Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Catherine Coolens, Ph. D Princess Margaret Cancer Center - UHN

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04197297    
Other Study ID Numbers: 18-5380
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Radiation Therapy
Radiotherapy
Biomarkers
Magnetic Resonance Imaging
Computed Tomography
Radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases