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

NCT07050836 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 24-0399.cc
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma (Any Grade) in the Brain; Glioma

Keywords

brain tumor, resection, glioma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 days

Study Arms (1)

Brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound

EXPERIMENTAL

Combination Product: Definity contrast during ultrasound

Interventions

Definity contrast during ultrasound COMBINATION_PRODUCT

Definity contrast injection given just prior to brain tumor surgery. Contrast enhanced ultrasound during brain tumor surgical resection to aid in brain tumor visualization.

Brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• D. Ryan Ormond, MD PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen Maitlen, BSN

CONTACT

303-724-1995; jennifer.maitlen@cuanschutz.edu

Terra Ornelas, BSN

CONTACT

303-724-7970; terra.ornelas@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 3, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)