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

Sponsor

University of Nebraska (Other)

Overall Status

Terminated

CT.gov ID

NCT02095353

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators propose to analyze the perfusion (blood flow) characteristics of blood tumors. The investigators will be comparing the use of two contrast agents in this study.

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Neoplasms

Study Design

Study Type:

Observational

Actual Enrollment :

6 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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