QSM and Regional DCE MRI Permeability Using GOCART Technique

University of Southern California

Status

Withdrawn

Conditions

Intracranial Neoplasm

Treatments

Device: Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Drug: Gadobenate Dimeglumine

Drug: Gadoterate Meglumine

Device: Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03091803

6B-16-1 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2017-00499 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients)
Willingness to comply with the study protocol

Exclusion criteria

Contraindications for MRI or GBCA (standard of care)
Abnormal renal function with estimated glomerular filtration rate (eGFR) less than 30 mL/min/m^2 based on creatinine obtained within last 30 days
History of previous administration of GBCA