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Trial record 14 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT02967380
Recruitment Status : Terminated (Insufficient Accrual)
First Posted : November 18, 2016
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Drug: Gadobenate Dimeglumine Drug: Gadobutrol Radiation: Gadopentetate Dimeglumine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
Actual Study Start Date : December 14, 2011
Actual Primary Completion Date : October 14, 2014
Actual Study Completion Date : October 14, 2015


Arm Intervention/treatment
Experimental: 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.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE-MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Gadobenate Dimeglumine
Given IV
Other Names:
  • Gd-BOPTA
  • MultiHance

Drug: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079

Radiation: Gadopentetate Dimeglumine
Given IV
Other Names:
  • Gadolinium DTPA
  • Gd-DTPA
  • Magnevist
  • Meglumine Gadopentetate
  • SH L 451 A
  • ZK 93035




Primary Outcome Measures :
  1. Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading [ Time Frame: Up to 7 days ]
    Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967380


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Meng Law University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02967380     History of Changes
Other Study ID Numbers: 0S-11-6
NCI-2014-01852 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
D1 2010-10
HS-11-00363
0S-11-6 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Sclerosis
Multiple Sclerosis
Glioblastoma
Glioma
Astrocytoma
Ependymoma
Gliosarcoma
Meningioma
Oligodendroglioma
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Brain Neoplasms
Neoplasms, Second Primary
Pinealoma
Hemangiopericytoma
Choroid Plexus Neoplasms
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue