NCT02967380

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

September 13, 2015

Last Update Submit

March 22, 2017

Conditions

Adult Anaplastic (Malignant) MeningiomaAdult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Choroid Plexus NeoplasmAdult Diffuse AstrocytomaAdult EpendymoblastomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Grade II MeningiomaAdult MedulloblastomaAdult Mixed GliomaAdult OligodendrogliomaAdult Papillary MeningiomaAdult Pineal Gland AstrocytomaAdult PineoblastomaAdult Primary Melanocytic Lesion of MeningesAdult Supratentorial Primitive Neuroectodermal TumorMalignant Adult Intracranial HemangiopericytomaMetastatic Malignant Neoplasm in the BrainMultiple SclerosisRecurrent Adult Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading

    Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.

    Up to 7 days

Study Arms (1)

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

EXPERIMENTAL

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 ImagingDrug: Gadobenate DimeglumineDrug: GadobutrolRadiation: Gadopentetate Dimeglumine

Interventions

Dynamic Contrast-Enhanced Magnetic Resonance ImagingPROCEDURE

Undergo DCE-MRI

Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
Gadobenate DimeglumineDRUG

Given IV

Also known as: Gd-BOPTA, MultiHance
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
GadobutrolDRUG

Given IV

Also known as: BAY86-4875, Gadograf, Gadovist, Protovis, ZK 135079
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
Gadopentetate DimeglumineRADIATION

Given IV

Also known as: Gadolinium DTPA, Gd-DTPA, Magnevist, Meglumine Gadopentetate, SH L 451 A, ZK 93035
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

MeningiomaAstrocytomaEpendymomaOligodendrogliomaChoroid Plexus NeoplasmsNeuroectodermal Tumors, PrimitiveGlioblastomaGliosarcomaMedulloblastomaGliomaPinealomaBrain NeoplasmsMultiple Sclerosis

Interventions

gadobenic acidgadobutrolGadolinium DTPA

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialCerebral Ventricle NeoplasmsBrain DiseasesCentral Nervous System DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Meng Law

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2015

First Posted

November 18, 2016

Study Start

December 14, 2011

Primary Completion

October 14, 2014

Study Completion

October 14, 2015

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)