Quantitative MRI in Assessing Disease in Patients With Brain Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02269111
• Other study ID #: VICC NEU1424
• Secondary ID: NCI-2014-01907VI
• Status: Terminated
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Tumors Metastatic to Brain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• diffusion-weighted magnetic resonance imaging
Undergo DW-MRI
• chemical exchange saturation transfer magnetic resonance imaging
Undergo CEST-MRI
• dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
• dynamic susceptibility contrast-enhanced magnetic resonance imaging
Undergo DSC-MRI

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	Mean transit time (MTT), as measured by DSC-MRI	Cox proportional hazards regression will be used to assess the association of MTT with change in tumor size.	Baseline

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial