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Contrast Enhanced Ultrasound in Neurosurgery to Improve Glioma Visualization and Border Demarcation

RECRUITINGEarly 1Sponsored by University of Colorado, Denver
Actively Recruiting
PhaseEarly 1
SponsorUniversity of Colorado, Denver
Started2025-12-05
Est. completion2026-12-31
Eligibility
Age18 Years – 95 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years – 95 YearsHealthy volunteers accepted
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.

Conditions3

CancerGliomaGlioma (Any Grade) in the Brain

Locations1 site

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Jennifer Maitlen, BSN303-724-1995jennifer.maitlen@cuanschutz.edu

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