Comparison of Contrast Agents for MRI Perfusion Analysis in Brain Tumor Patients

NCT ID: NCT02095353

Last Updated: 2023-08-23

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-01

Study Completion Date

2017-03-07

Brief Summary

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This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.

Detailed Description

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This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.

Conditions

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Central Nervous System Neoplasms

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor.

Exclusion Criteria

* Renal failure (GFR \<45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines.
* Allergic reactions to MRI contrast agents.
* Subjects who do not fit the criteria for the population we are evaluating.
* Subjects should not participate in this study if they have any of the following conditions:

* Anxiety attacks
* Panic disorder
* Claustrophobia
* Pregnant, or trying to become pregnant
* Breast feeding
* Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects.
* If a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical MRI examination to safely perform the research MRI examination that subject would be excluded.Subjects not being able to return for a follow-up examination
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew White, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0585-13-FB

Identifier Type: -

Identifier Source: org_study_id

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