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

Terminated

• Conditions: Central Nervous System Neoplasms

• Registration Number: NCT02095353
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Study Start: 2014-09-01
• Primary Completion: 2017-03-07
• Study Completion: 2017-03-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-19
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States