QSM and Regional DCE MRI Permeability Using GOCART Technique

Intracranial Neoplasm Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03091803
• Other study ID #: 6B-16-1
• Secondary ID: NCI-2017-004996B
• Status: Withdrawn
• Start date: April 4, 2017
• Est. completion date: April 4, 2021

Study information

• Verified date: April 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 4, 2021
• Est. primary completion date: April 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Neoplasm
• Neoplasms

Intervention

Device:
• Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo GOCART DCE MRI

Drug:
• Gadobenate Dimeglumine
Given IV
• Gadoterate Meglumine
Given IV

Device:
• Magnetic Resonance Imaging
Undergo QSM and T1WI imaging

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QSM score	Descriptive statistics will be used to describe the magnitude of Gd deposition measured by QSM score in each of the two study groups. Histograms will be generated for QSM score at each time point as well as the change from the baseline for each group. The descriptive statistics will be used to calculate the mean, median, interquartile range, and standard deviation. Box plot and overlying histogram will be used to illustrate the distribution of change in Gd deposition between gadobenate dimeglumine and gadoterate meglumine group. Correlation between QSM score versus (vs.) kTrans and QSM score v	Baseline up to 18 months
Secondary	Change in T1WI signal intensity ratio	Descriptive statistics will be used to describe the magnitude of Gd deposition measured by T1WI signal intensity ratio in each of the two study groups. Histograms will be generated for T1WI signal intensity ratio score at each time point as well as the change from the baseline for each group. The descriptive statistics will be used to calculate the mean, median, interquartile range, and standard deviation. Box plot and overlying histogram will be used to illustrate the distribution of change in Gd deposition between gadobenate dimeglumine and gadoterate meglumine group. Correlation between T1W	Baseline up to 18 months
Secondary	kTrans and Ve signal using GOCART 3D MRI	The signal (kTrans and Ve) will be obtained in voxel level then taking average within the region of interest (ROI). ROI will be placed on the pons, bilateral globi pallidi, thalami and dentate nuclei to obtain the average signal within the ROI. Averages of all bilateral measurements will be used to calculate the final signal for kTrans and Ve. The final kTrans and Ve signal will only be used to assess the correlation with QSM and T1WI signal intensity ratios.	Up to 18 months