NCT02967380

Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases

Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial compares gadobutrol with standard of care contrast agents, gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the central nervous system. It is not yet known whether gadobutrol is more effective than standard of care contrast agents before DCE-MRI in diagnosing patients with multiple sclerosis, grade II-IV glioma, or tumors that have spread to the brain.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether Gadavist® (gadobutrol) is consistent with Magnevist® (gadopentetate dimeglumine) or Multihance (gadobenate dimeglumine) in the preoperative grading of gliomas utilizing DCE MRI. II. To determine whether Gadavist® is consistent with Magnevist® or Multihance in identifying the number of cerebral metastases from a primary cancer elsewhere in the body using T1-weighted post contrast MRI. III. To determine if Gadavist® is consistent with Magnevist® or Multihance in identifying multiple sclerosis (MS) plaques using T1-weighted post contrast MRI. IV. To determine if Gadavist® produces similar MR perfusion/permeability values of MS lesions as Magnevist® or Multihance. V. Descriptive analysis to present the different rating patterns of Gadavist® versus Magnevist® or Multihance in differentiating therapeutic necrosis from recurrent tumor in gliomas utilizing DCE MRI. OUTLINE: Patients receive standard of care gadopentetate dimeglumine intravenously (IV) twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7. After completion of study, patients are followed up at 7 days.

Conditions

• Adult Anaplastic (Malignant) Meningioma
• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Brain Stem Glioma
• Adult Choroid Plexus Neoplasm
• Adult Diffuse Astrocytoma
• Adult Ependymoblastoma
• Adult Ependymoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Grade II Meningioma
• Adult Medulloblastoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Papillary Meningioma
• Adult Pineal Gland Astrocytoma
• Adult Pineoblastoma
• Adult Primary Melanocytic Lesion of Meninges
• Adult Supratentorial Primitive Neuroectodermal Tumor
• Malignant Adult Intracranial Hemangiopericytoma
• Metastatic Malignant Neoplasm in the Brain
• Multiple Sclerosis
• Recurrent Adult Brain Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo DCE-MRI
DRUG	Gadobenate Dimeglumine	Given IV
DRUG	Gadobutrol	Given IV
RADIATION	Gadopentetate Dimeglumine	Given IV

Timeline

• Start date: 2011-12-14
• Primary completion: 2014-10-14
• Completion: 2015-10-14
• First posted: 2016-11-18
• Last updated: 2017-03-27

Locations

1 site across 1 country: United States