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

University of Colorado Denver (CU Denver)

Status and phase

Enrolling

Early Phase 1

Conditions

Glioma

Glioma (Any Grade) in the Brain

Treatments

Combination Product: Definity contrast during ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT07050836

24-0399.cc

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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.