Quantitative MRI in Assessing Disease in Patients With Brain Tumors

NCT ID: NCT02269111

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tumors Metastatic to Brain Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

diffusion-weighted magnetic resonance imaging

Intervention Type PROCEDURE

Undergo DW-MRI

chemical exchange saturation transfer magnetic resonance imaging

Intervention Type PROCEDURE

Undergo CEST-MRI

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type PROCEDURE

Undergo DCE-MRI

dynamic susceptibility contrast-enhanced magnetic resonance imaging

Intervention Type PROCEDURE

Undergo DSC-MRI

Interventions

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diffusion-weighted magnetic resonance imaging

Undergo DW-MRI

Intervention Type PROCEDURE

chemical exchange saturation transfer magnetic resonance imaging

Undergo CEST-MRI

Intervention Type PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Undergo DCE-MRI

Intervention Type PROCEDURE

dynamic susceptibility contrast-enhanced magnetic resonance imaging

Undergo DSC-MRI

Intervention Type PROCEDURE

Other Intervention Names

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diffusion-weighted MRI CEST MRI DCE-MRI DSC-MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Albert Attia

Assistant Professor of Radiation Oncology; Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert Attia, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

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NCI-2014-01907

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC NEU1424

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC NEU1424

Identifier Type: -

Identifier Source: org_study_id

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