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

University of Southern California

Status: Terminated

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

Treatments: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Gadobenate Dimeglumine; Drug: Gadobutrol; Radiation: Gadopentetate Dimeglumine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02967380

D1 2010-10

0S-11-6 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2014-01852 (Registry Identifier)

HS-11-00363

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)

Experimental group

Description:

Patients receive standard of care gadopentetate dimeglumine 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.

Treatment:

Radiation: Gadopentetate Dimeglumine

Drug: Gadobutrol

Drug: Gadobenate Dimeglumine

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging