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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-14

Study Completion Date

2015-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

3T MRI Biomarkers of Glioma Treatment Response

NCT01996527

Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma +4 more

TERMINATED EARLY_PHASE1

Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions

NCT04132843

Brain Neoplasm Lymphoma Metastatic Malignant Neoplasm in the Brain +1 more

COMPLETED NA

MRI Gadopiclenol Enhanced Imaging of CNS Tumors

NCT06127810

Image

WITHDRAWN

Hyperpolarized Imaging in Diagnosing Participants With Glioma

NCT03739411

Glioma

RECRUITING PHASE1

Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma

NCT01342757

Adult Glioblastoma Depression Recurrent Adult Brain Tumor

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DCE-MRI

Gadobenate Dimeglumine

Intervention Type DRUG

Given IV

Gadobutrol

Intervention Type DRUG

Given IV

Gadopentetate Dimeglumine

Intervention Type RADIATION

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE-MRI

Intervention Type PROCEDURE

Gadobenate Dimeglumine

Given IV

Intervention Type DRUG

Gadobutrol

Given IV

Intervention Type DRUG

Gadopentetate Dimeglumine

Given IV

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DCE MRI DCE-MRI DYNAMIC CONTRAST ENHANCED MRI Gd-BOPTA MultiHance BAY86-4875 Gadograf Gadovist Protovis ZK 135079 Gadolinium DTPA Gd-DTPA Magnevist Meglumine Gadopentetate SH L 451 A ZK 93035

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No