Clinical trial NCT03091803: QSM and Regional DCE MRI Permeability Using GOCART Technique
Official title: 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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intracranial Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen at USC/Norris Comprehensive Cancer Center who are found to have suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients) will be recruited for the study.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in QSM score
timeFrame: Baseline up to 18 months
Secondary outcomes:
measure: Change in T1WI signal intensity ratio
timeFrame: Baseline up to 18 months
measure: kTrans and Ve signal using GOCART 3D MRI
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Alexander Lerner
role: PRINCIPAL_INVESTIGATOR
References: