QSM and Regional DCE MRI Permeability Using GOCART Technique

NCT03091803 | Withdrawn DMC FDA Device

• 3 other identifiers: 6B-16-1NCI-2017-00499P30CA014089
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in T1WI signal intensity ratio

  Baseline up to 18 months

• kTrans and Ve signal using GOCART 3D MRI

  Up to 18 months

Study Arms (2)

Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)

Patients undergo standard of care QSM and T1WI. Patients then receive gadobenate dimeglumine IV and undergo GOCART DCE MRI over 60 minutes.

Device: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Gadobenate Dimeglumine; Device: Magnetic Resonance Imaging

Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)

Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.

Device: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Gadoterate Meglumine; Device: Magnetic Resonance Imaging

Interventions

Dynamic Contrast-Enhanced Magnetic Resonance Imaging DEVICE

Undergo GOCART DCE MRI

Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI); Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)

Gadobenate Dimeglumine DRUG

Given IV

Also known as: Gd-BOPTA, MultiHance

Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)

Gadoterate Meglumine DRUG

Given IV

Also known as: DOTAREM, Gd-DOTA

Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)

Magnetic Resonance Imaging DEVICE

Undergo QSM and T1WI imaging

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI); Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging; gadobenic acid; gadoterate meglumine; gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alexander Lerner

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: April 4, 2017
• Primary Completion: April 4, 2020
• Study Completion: April 4, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (1)