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

Not Applicable

Terminated

• Conditions: Adult Anaplastic (Malignant) Meningioma; 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
• Interventions: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Gadobenate Dimeglumine; Drug: Gadobutrol; Radiation: Gadopentetate Dimeglumine

• Registration Number: NCT02967380
• Lead Sponsor: University of Southern California

Brief 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.

Study Timeline

• Study Start: 2011-12-14
• Primary Completion: 2014-10-14
• Study First Submitted: 2015-09-13
• Study Completion: 2015-10-14
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	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.
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)	Gadobenate Dimeglumine	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.
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)	Gadopentetate Dimeglumine	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.
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)	Gadobutrol	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.

Primary Outcome Measures

Name	Time	Method
Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading	Up to 7 days	Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States