Quantitative MRI in Assessing Disease in Patients With Brain Tumors

May 25, 2018 updated by: Albert Attia, Vanderbilt-Ingram Cancer Center

Quantitative High-Field Magnetic Resonance Imaging (MRI) for Assessing Brain Metastases

This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). In addition to routine care brain imaging of the brain, this study will include advanced multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the tumor. Performing extra scans during MRI provides more information about the metastases and may better predict treatment response.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To correlate pre-treatment measures of biophysical parameters in metastases-obtained using advanced, quantitative MRI techniques in patients receiving standard-of-care (SOC) therapy for 1-4 brain metastases-with treatment-induced changes in lesion size, time-to-progression (TTP), and overall survival (OS).

OUTLINE:

Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, diffusion-weighted (DW)-MRI, chemical exchange saturation transfer (CEST), and combined dynamic contrast enhanced (DCE)-MRI/dynamic susceptibility contrast (DSC)-MRI at baseline.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must sign an Institutional Review Board (IRB)-approved informed consent document

  • Patients must have been diagnosed with one of the following:

    • Primary brain tumor (glioma, GBM etc); or
    • Up to 10 brain metastases
  • Patients must have been diagnosed with 1-4 brain metastases
  • At least one of the brain metastases must measure 5 mm (or more) in short axis diameter in the axial plane

  • Patients must be scheduled to undergo standard brain cancer interventions:

    • Chemotherapy or targeted antiangiogenic therapy, in the case of primary brain tumor; or
    • Stereotaxic radiotherapy (SRS) or whole brain radiotherapy (WBRT), in the case of brain metastases.
  • Patients must be scheduled to receive a 3-Tesla (3T) MRI exam as part of their standard of care (this exam will be modified to also include pulse sequences with are for research only)

Exclusion Criteria:

  • Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic).
  • Patients who are scheduled to receive a 1.5T MRI exam
  • Patients incapable of giving informed written consent, due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders.
  • Patients scoring 14.5 or lower on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) questionnaire will not be allowed on the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (hybrid MRI)
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline.
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Other Names:
  • DCE-MRI
Procedure: chemical exchange saturation transfer magnetic resonance imaging
Undergo CEST-MRI
Other Names:
  • CEST MRI
Procedure: diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
Other Names:
  • diffusion-weighted MRI
Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imaging
Undergo DSC-MRI
Other Names:
  • DSC-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume transfer constant (Ktrans), as measured by DCE-MRI
Time Frame: Baseline
The ability of pre-treatment estimates of Ktrans to predict objective tumor response by Response Evaluation Criteria in Solid Tumors or Macdonald criteria after therapy will be assessed using the proportional odds model.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amide proton transfer asymmetry (APTasym) as measured by CEST
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of APTasym with change in tumor size.
Baseline
Apparent diffusion coefficient (ADC), as measured by DW-MRI
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of ADC with change in tumor size.
Baseline
Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of Ve with change in tumor size.
Baseline
Plasma volume fraction (Vp), as measured by DCE-MRI
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of Vp with change in tumor size.
Baseline
Cerebral blood volume (CBV), as measured by DSC-MRI
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of CBV with change in tumor size.
Baseline
Cerebral blood flow (CBF), as measured by DSC-MRI
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of CBF with change in tumor size.
Baseline
Mean transit time (MTT), as measured by DSC-MRI
Time Frame: Baseline
Cox proportional hazards regression will be used to assess the association of MTT with change in tumor size.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Albert Attia, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC NEU1424 (Other Identifier: Vanderbilt-Ingram Cancer Center)
  • P30CA068485 (U.S. NIH Grant/Contract)
  • NCI-2014-01907 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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