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Quantitative MRI in Assessing Disease in Patients With Brain Tumors

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Terminated

Conditions

Tumors Metastatic to Brain
Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Procedure: chemical exchange saturation transfer magnetic resonance imaging
Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imaging
Procedure: diffusion-weighted magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02269111
NCI-2014-01907 (Registry Identifier)
P30CA068485 (U.S. NIH Grant/Contract)
VICC NEU1424 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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