Clinical trial NCT02967380: Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases
Official title: Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Meng Law
role: PRINCIPAL_INVESTIGATOR
References: