Study Results
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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TERMINATED
EARLY_PHASE1
7 participants
INTERVENTIONAL
2012-05-31
2016-01-01
Brief Summary
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Detailed Description
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I. To correlate treatment-induced changes in quantitative MRI-based biomarkers-specifically, those sensitive to tumor protein content (amide proton transfer asymmetry \[APTasym\] from chemical exchange saturation transfer \[CEST\]), cellularity (apparent diffusion coefficient \[ADC\] from diffusion-weighted imaging \[DWI\]), and blood flow (volume transfer constant \[K\^trans\] from dynamic contrast-enhanced \[DCE\]; cerebral blood flow \[CBF\] from dynamic susceptibility contrast \[DSC\])-with treatment-induced changes in tumor size, measured via standard anatomic MRI.
II. To correlate treatment-induced changes in the above quantitative MRI endpoints with patient progression-free survival (PFS).
OUTLINE:
Patients undergo measurement of tumor protein content using CEST-MRI, cellularity using DWI-MRI, and blood flow using DCE-MRI and DSC-MRI within 2 weeks of treatment and at 2 and 4 weeks after initiation of treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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3-Tesla magnetic resonance imaging
Patients undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and blood flow (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) no more than 2 weeks before, and 2 and 4 weeks after, the initiation of treatment.
3-Tesla magnetic resonance imaging
3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI
CEST-MRI
Undergo CEST-MRI
DW-MRI
Undergo DWI-MRI
DCE-MRI
Undergo DCE-MRI
DSC-MRI
Undergo DSC-MRI
IV administration of gadolinium-containing contrast agent
Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast
Interventions
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3-Tesla magnetic resonance imaging
3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI
CEST-MRI
Undergo CEST-MRI
DW-MRI
Undergo DWI-MRI
DCE-MRI
Undergo DCE-MRI
DSC-MRI
Undergo DSC-MRI
IV administration of gadolinium-containing contrast agent
Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have been diagnosed with high-grade glioma:
* World Health Organization (WHO) grade III: anaplastic astrocytoma, oligodendroglioma, ependymoma, or oligoastrocytoma; OR
* WHO grade IV: glioblastoma multiforme; or neuroepithelial tumors of uncertain origin (polar spongioblastoma, astroblastoma, or gliomatosis cerebri)
* As measured by conventional high spatial resolution MRI, the minimum diameter of the primary lesion (short axis) should be at least 5 mm
* Patients must be scheduled to receive: 1) standard chemotherapy with/without radiation therapy; OR 2) single-agent bevacizumab (Avastin)
Exclusion Criteria
* Patients with metastatic disease
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who have any type of ferromagnetic bioimplant that could potentially be displaced
* Patients who have cerebral aneurysm clips
* Patients who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
* Patients with inadequate renal function (creatinine \>= 1.5 times upper limit of normal) or acute or chronic renal insufficiency (glomerular filtration rate \< 20 ml/min)
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
* Patients incapable of giving informed written consent, for the following reasons:
* Inability to adhere to the experimental protocols for any reason
* Inability to communicate with the research team
* Limited ability to give informed 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 at San Diego (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent Questionnaire will be excluded
* Prisoners or other individuals deemed to be susceptible to coercion
* For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Thomas Yankeelov
Professor of Radiology and Radiological Sciences, Director of Cancer Imaging Research
Principal Investigators
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Chad Quarles
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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NCI-2013-02195
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC NEU 1268
Identifier Type: -
Identifier Source: org_study_id
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