NCT01996527

3T MRI Biomarkers of Glioma Treatment Response

Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving treatment for high-grade gliomas.

Detailed description

PRIMARY OBJECTIVES: 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

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DEVICE	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
DEVICE	CEST-MRI	Undergo CEST-MRI
DEVICE	DW-MRI	Undergo DWI-MRI
DEVICE	DCE-MRI	Undergo DCE-MRI
DEVICE	DSC-MRI	Undergo DSC-MRI
DRUG	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

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-11-23
• Completion: 2016-01-01
• First posted: 2013-11-27
• Last updated: 2017-04-17

Locations

1 site across 1 country: United States