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

Stopped early · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02967380

Run by

University of Southern California

People needed

14

Starts

2011-12-14

Expected to finish

2015-10-14

Last updated by the study team

2017-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of multiple sclerosis, known or suspected diagnosis of glioma, or known or suspected diagnosis of cerebral metastasis
• Scheduled or to be scheduled for a follow-up MRI per standard of care for their disease
• Minimum permitted time intervals from prior treatments are 6 weeks for intracranial surgery
• Adequate renal function (serum creatinine =< 1.5 mg/dL)
• Subject must sign a study-specific informed consent

You may not qualify if…

• Medically unstable
• Renal impairment (glomerular filtration rate [GFR] < 60 mL/min/1.73m\^2) or history of existing nephrogenic systemic fibrosis (NSF)
• Cardiac pacemaker
• A serious concurrent infection, illness, or medical condition
• Subjects with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
• Subject is claustrophobic and cannot cooperate for the MRI
• Females who are pregnant or nursing
• Any other condition that would compromise the scan with reasonable safety

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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