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
|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|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Drug: Gadobenate Dimeglumine
Radiation: Gadopentetate Dimeglumine
- 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.
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
|United States, California|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Meng Law||University of Southern California|