QSM and Regional DCE MRI Permeability Using GOCART Technique
NCT ID: NCT03091803
Last Updated: 2021-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2017-04-04
2021-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo GOCART DCE MRI
Gadobenate Dimeglumine
Given IV
Magnetic Resonance Imaging
Undergo QSM and T1WI 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.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo GOCART DCE MRI
Gadoterate Meglumine
Given IV
Magnetic Resonance Imaging
Undergo QSM and T1WI imaging
Interventions
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Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo GOCART DCE MRI
Gadobenate Dimeglumine
Given IV
Gadoterate Meglumine
Given IV
Magnetic Resonance Imaging
Undergo QSM and T1WI imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to comply with the study protocol
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Alexander Lerner
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2017-00499
Identifier Type: REGISTRY
Identifier Source: secondary_id
6B-16-1
Identifier Type: OTHER
Identifier Source: secondary_id
6B-16-1
Identifier Type: -
Identifier Source: org_study_id
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