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

Gadobenate Dimeglumine Compared to Gadobutrol for MRI Perfusion Analysis in Brain Tumor Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02095353

Enrollment

Registered

2014-03-24

Start date

2014-09-01

Completion date

2017-03-07

Last updated

2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Neoplasms

Keywords

Brain tumor, extraaxial, metastasis, glioma, primary brain tumor, secondary brain tumor, MRI, perfusion, dynamic contrast enhancement, CBV, CBF, ktrans

Brief summary

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

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Degree of contrast induced signal changes with dynamic imaging of brain tumors	2 weeks	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.

Secondary

Measure	Time frame	Description
Calculate differences in cerebral blood volume, ktrans and flow in brain tumors	2 weeks	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.

Countries

United States

Outcome results