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QSM and Regional DCE MRI Permeability Using GOCART Technique

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ClinicalTrials.gov Identifier: NCT03091803
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment
Intracranial Neoplasm Device: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Drug: Gadobenate Dimeglumine Drug: Gadoterate Meglumine Device: Magnetic Resonance Imaging

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : April 4, 2020
Estimated Study Completion Date : April 4, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Undergo GOCART DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Gadobenate Dimeglumine
Given IV
Other Names:
  • Gd-BOPTA
  • MultiHance

Device: Magnetic Resonance Imaging
Undergo QSM and T1WI imaging
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear 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
Undergo GOCART DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Gadoterate Meglumine
Given IV
Other Names:
  • DOTAREM
  • Gd-DOTA

Device: Magnetic Resonance Imaging
Undergo QSM and T1WI imaging
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging




Primary Outcome Measures :
  1. Change in QSM score [ Time Frame: Baseline up to 18 months ]
    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


Secondary Outcome Measures :
  1. Change in T1WI signal intensity ratio [ Time Frame: Baseline up to 18 months ]
    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

  2. kTrans and Ve signal using GOCART 3D MRI [ Time Frame: Up to 18 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091803


Contacts
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Contact: Rosaura Diaz 323-442-7469 Rosaura.diaz@med.usc.edu
Contact: Bushan Desai 323-442-7469 bhushand@usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Alexander Lerner    323-865-9914    lernera@med.usc.edu   
Principal Investigator: Alexander Lerner         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alexander Lerner University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03091803     History of Changes
Other Study ID Numbers: 6B-16-1
NCI-2017-00499 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6B-16-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action