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

Early Phase 1RecruitingNCT07050836

University of Colorado, Denver100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Glioma (Any Grade) in the Brain Glioma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Primary Objective

This study plans to learn more about using contrast enhanced ultrasound (CEUS) to better identify normal brain from tumor in brain tumor surgery. The goal of brain tumor surgery is to remove as much of the tumor 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. The ability of CEUS to improve visualization of brain tumor during surgery will be measured by the surgeon during surgery. The surgeon will also take images of the surgery site during surgery with the contrast enhanced ultrasound machine. These images will be studied later to determine if CEUS improves the surgeons ability to better visualize tumor during surgery.

Time frame: Up to 3 days