Quantitative MRI in Assessing Disease in Patients With Brain Tumors

Vanderbilt-Ingram Cancer Center10 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Tumors Metastatic to Brain Unspecified Adult Solid Tumor, Protocol Specific

Interventions

diffusion-weighted magnetic resonance imagingPROCEDURE

Undergo DW-MRI

chemical exchange saturation transfer magnetic resonance imagingPROCEDURE

Undergo CEST-MRI

dynamic contrast-enhanced magnetic resonance imagingPROCEDURE

Undergo DCE-MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Volume transfer constant (Ktrans), as measured by DCE-MRI

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.

Time frame: Baseline

Secondary Outcomes

Amide proton transfer asymmetry (APTasym) as measured by CEST

Cox proportional hazards regression will be used to assess the association of APTasym with change in tumor size.

Time frame: Baseline

Apparent diffusion coefficient (ADC), as measured by DW-MRI

Cox proportional hazards regression will be used to assess the association of ADC with change in tumor size.

Time frame: Baseline

Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI

Cox proportional hazards regression will be used to assess the association of Ve with change in tumor size.

Time frame: Baseline

Plasma volume fraction (Vp), as measured by DCE-MRI

Cox proportional hazards regression will be used to assess the association of Vp with change in tumor size.

Time frame: Baseline

Cerebral blood volume (CBV), as measured by DSC-MRI

Cox proportional hazards regression will be used to assess the association of CBV with change in tumor size.

Time frame: Baseline

Cerebral blood flow (CBF), as measured by DSC-MRI

Cox proportional hazards regression will be used to assess the association of CBF with change in tumor size.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.