Clinical trial · Interventional
Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases
Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (25)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Ependymoma | Adult Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic (Malignant) Meningioma | Adult Anaplastic (Malignant) Meningioma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Brain Stem Glioma | Adult Brain Stem Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Choroid Plexus Neoplasm | Adult Choroid Plexus Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Gadobenate Dimeglumine | Drug | — | UNRESOLVED |
| Gadobutrol | Drug | — | UNRESOLVED |
| Gadopentetate Dimeglumine | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
- description
- 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.
- interventionNames
- Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Drug: Gadobenate Dimeglumine
- Drug: Gadobutrol
- Radiation: Gadopentetate Dimeglumine
Primary outcomes (1)
- measure
- Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading
- timeFrame
- Up to 7 days
- description
- Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available