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Purpose

This study plans to learn more about using contrast enhanced ultrasound (CEUS) in brain tumor surgery. The goal of glioma brain tumor surgery is to remove as much of the glioma as possible. Tumor tissue that is close to normal brain tissue can look very similar. This can make it difficult for the surgeon to remove all the tumor. In this study, we hope to learn if using CEUS during brain tumor surgery will allow the brain surgeon to better see and remove all the tumor tissue.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 95 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Able to sign and date the consent form - Stated willingness to comply with all study procedures and be available for the duration of the study - Be a male or female aged 18-95 - Have a planned standard of care surgery for presumed primary or known recurrent glioma - WHO performance status </= 2 (equivalent Karnofsky Performance Status, KPS>/= 70) - Patient of childbearing potential must have a negative pregnancy test within 14 days of inclusion

Exclusion Criteria

  • Patient at high risk of surgical site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, and/or previously infected surgical field, or any other condition that is of increased infectious risk in the opinion of the neurosurgeon) - Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in the contrast agent. - Patient with known or suspected active or chronic infections. - Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mm Hg), uncontrolled systemic hypertension, or adult respiratory distress syndrome. - Pregnant, or breastfeeding patient. - Patient with known sickle cell disease. - Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care. - Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound
  • Combination Product: Definity contrast during ultrasound
    Definity contrast injection given just prior to brain tumor surgery. Contrast enhanced ultrasound during brain tumor surgical resection to aid in brain tumor visualization.

Recruiting Locations

University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
Jennifer Maitlen, BSN
303-724-1995
jennifer.maitlen@cuanschutz.edu

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Jen Maitlen, BSN
303-724-1995
jennifer.maitlen@cuanschutz.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.