Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 96 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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2015
First Posted Date  ICMJE November 18, 2016
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE December 14, 2011
Actual Primary Completion Date October 14, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02967380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
  • Drug: Gadobenate Dimeglumine
  • Drug: Gadobutrol
  • Radiation: Gadopentetate Dimeglumine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 15, 2016)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 14, 2015
Actual Primary Completion Date October 14, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02967380
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Meng Law University of Southern California
PRS Account University of Southern California
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP