Quantitative MRI in Assessing Disease in Patients With Brain Tumors

NCT02269111 | Terminated DMC

• 3 other identifiers: VICC NEU1424NCI-2014-01907P30CA068485
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumors Metastatic to Brain; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Amide proton transfer asymmetry (APTasym) as measured by CEST

  Baseline

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

  Baseline

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

  Baseline

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

  Baseline

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

  Baseline

Study Arms (1)

Diagnostic (hybrid MRI)

EXPERIMENTAL

Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline.

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

Interventions

diffusion-weighted magnetic resonance imaging PROCEDURE

Undergo DW-MRI

Also known as: diffusion-weighted MRI

Diagnostic (hybrid MRI)

chemical exchange saturation transfer magnetic resonance imaging PROCEDURE

Undergo CEST-MRI

Also known as: CEST MRI

Diagnostic (hybrid MRI)

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo DCE-MRI

Also known as: DCE-MRI

Diagnostic (hybrid MRI)

dynamic susceptibility contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo DSC-MRI

Also known as: DSC-MRI

Diagnostic (hybrid MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Albert Attia, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology; Radiation Oncologist

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: April 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

US (1)