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

Central Nervous System Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02095353
• Other study ID #: 0585-13-FB
• Status: Terminated
• Start date: September 1, 2014
• Est. completion date: March 7, 2017

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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