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FDA safety concerns with repeated use of gadolinium-based contrast; subjects received additional dose of contrast with no direct clinical benefit
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This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.
This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of contrast induced signal changes with dynamic imaging of brain tumors | Two contrast agents will be administered in different MRI imaging sessions. Will measure how the appearance of brain tumors change during dynamic first pass contrast administration. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate differences in cerebral blood volume, ktrans and flow in brain tumors | Calculations will be made of cerebral blood volume, cerebral blood flow or ktrans in brain tumors when different contrast agents are administered. These parameters reflect vasculature and angiogenesis in tumors. | 2 weeks |
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Inclusion Criteria:
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:
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
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Adults with brain tumors who have had a brain MRI ordered.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew White, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Nebraska Medical Center | Omaha | Nebraska | 68198-1045 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |