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

NCT02095353 | Terminated

• 1 other identifier: 0585-13-FB
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Calculate differences in cerebral blood volume, ktrans and flow in brain tumors

  2 weeks

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with brain tumors who have had a brain MRI ordered.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198-1045, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Neoplasm Metastasis; Glioma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Matthew White, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 24, 2014
• Study Start: September 1, 2014
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2017
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)