Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases

• Status: Terminated
• Trial end date: 2015-10-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pentetic Acid

Criteria

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