Clinical trial NCT02269111: Quantitative MRI in Assessing Disease in Patients With Brain Tumors
Official title: Quantitative High-Field Magnetic Resonance Imaging (MRI) for Assessing Brain Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tumors Metastatic to Brain
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-10-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume transfer constant (Ktrans), as measured by DCE-MRI
timeFrame: Baseline
Secondary outcomes:
measure: Amide proton transfer asymmetry (APTasym) as measured by CEST
timeFrame: Baseline
measure: Apparent diffusion coefficient (ADC), as measured by DW-MRI
timeFrame: Baseline
measure: Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI
timeFrame: Baseline
measure: Plasma volume fraction (Vp), as measured by DCE-MRI
timeFrame: Baseline
measure: Cerebral blood volume (CBV), as measured by DSC-MRI
timeFrame: Baseline
measure: Cerebral blood flow (CBF), as measured by DSC-MRI
timeFrame: Baseline
measure: Mean transit time (MTT), as measured by DSC-MRI
timeFrame: Baseline
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Albert Attia, MD
role: PRINCIPAL_INVESTIGATOR
References: