NCT03091803

QSM and Regional DCE MRI Permeability Using GOCART Technique

Evaluation of Regional Gadolinium Retention in the Brain Using QSM With Correlation to Regional DCE MRI Permeability Using GOCART Technique in Intracranial Neoplasm Patients Receiving Gadobenate Dimeglumine (MultiHance) or Gadoterate Meglumine (Dotarem)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may help to gather information regarding brain changes associated with gadolinium deposits during 8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.

Detailed description

PRIMARY OBJECTIVES: I. To obtain preliminary data (e.g. mean, variance, distribution) in the regional brain parenchymal changes associated with gadolinium (Gd) deposition during 8 to 18 months period after administration of gadolinium based contrast agents (GBCA) to Gd naive intracranial neoplasm patients who will be randomized to gadobenate dimeglumine (MultiHance) or gadoterate meglumine (Dotarem). II. To explore if areas of increased regional Gd deposition at individual level are correlated with baseline regional DCE permeability metrics such as volume transfer coefficient reflecting vascular permeability (kTrans), extracellular volume ratio reflecting vascular permeability (ve) and plasma volume (vp) in intracranial neoplasm patients. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard of care QSM and T1 weighted imaging (T1WI). Patients then receive gadobenate dimeglumine intravenously (IV) and undergo GOCART DCE MRI over 60 minutes. ARM II: Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes. After completion of study, patients are followed up at 8-18 months.

Conditions

• Intracranial Neoplasm

Interventions

Type	Name	Description
DEVICE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo GOCART DCE MRI
DRUG	Gadobenate Dimeglumine	Given IV
DRUG	Gadoterate Meglumine	Given IV
DEVICE	Magnetic Resonance Imaging	Undergo QSM and T1WI imaging

Timeline

• Start date: 2017-04-04
• Primary completion: 2020-04-04
• Completion: 2021-04-04
• First posted: 2017-03-27
• Last updated: 2021-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study