QSM and Regional DCE MRI Permeability Using GOCART Technique

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.

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