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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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