Glioma, Glioma (Any Grade) in the Brain
Conditions
Keywords
brain tumor, resection, glioma
Brief 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.
Interventions
COMBINATION_PRODUCTDefinity 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Up to 3 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORD. Ryan Ormond, MD PhD
University of Colorado, Denver
Outcome results
None listed