Adult Anaplastic (Malignant) MeningiomaNCT02967380
Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Gadobenate Dimeglumine and Gadobutrol in people with Adult Anaplastic (Malignant) Meningioma and Adult Anaplastic Astrocytoma, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Anaplastic (Malignant) Meningioma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma
- What is being tested?
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Gadobenate Dimeglumine and Gadobutrol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2011to 14 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Adult Anaplastic (Malignant) Meningioma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Choroid Plexus Neoplasm
- Being tested
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Gadobenate Dimeglumine, Gadobutrol, Gadopentetate Dimeglumine
- Medical subject headings
- Meningioma, Astrocytoma, Ependymoma, Oligodendroglioma, Choroid Plexus Neoplasms, Neuroectodermal Tumors, Primitive, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE-MRI
Gadobenate DimeglumineDrug
Also called Gd-BOPTA, MultiHance
Given IV
GadobutrolDrug
Also called BAY86-4875, Gadograf, Gadovist, Protovis
Given IV
Gadopentetate DimeglumineRadiation
Also called Gadolinium DTPA, Gd-DTPA, Magnevist, Meglumine Gadopentetate
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Gadobenate Dimeglumine; Drug: Gadobutrol; Radiation: Gadopentetate Dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start14 Dec 2011
- Primary completion14 Oct 2014
- Study completion14 Oct 2015
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Anaplastic (Malignant) MeningiomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Meng Law, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967380
- Sponsor's protocol ID
- 0S-11-6
- Other IDs
- NCI-2014-01852, D1 2010-10, HS-11-00363, 0S-11-6, P30CA014089
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
- ClinicalTrials.gov ID
- NCT02967380
- Acronym / sponsor ID
- 0S-11-6
- Conditions
- Adult Anaplastic (Malignant) Meningioma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Choroid Plexus Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Dec 2011 (actual)
- Primary completion
- 14 Oct 2014 (actual)
- Study completion
- 14 Oct 2015 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Drug: Gadobenate Dimeglumine, Drug: Gadobutrol, Radiation: Gadopentetate DimegluminePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE-MRI | Procedure or surgery | Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI) |
| Gadobenate DimeglumineAlso: Gd-BOPTA, MultiHanceGiven IV | Drug | Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI) |
| GadobutrolAlso: BAY86-4875, Gadograf, Gadovist, ProtovisGiven IV | Drug | Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI) |
| Gadopentetate DimeglumineAlso: Gadolinium DTPA, Gd-DTPA, Magnevist, Meglumine GadopentetateGiven IV | Radiation | Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI) |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Law principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Gadobenate Dimeglumine and Gadobutrol in people with Adult Anaplastic (Malignant) Meningioma and Adult Anaplastic Astrocytoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.