Using contrast-enhanced ultrasound to better see and remove glioma during brain surgery
Contrast Enhanced Ultrasound in Neurosurgery to Improve Glioma Visualization and Border Demarcation
EARLY_PHASE1 · University of Colorado, Denver · NCT07050836
We will try contrast-enhanced ultrasound (Definity) during brain tumor operations to help surgeons more clearly see and remove gliomas in adults.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07050836 on ClinicalTrials.gov |
What this trial studies
This single-center, early-phase interventional study adds intraoperative contrast-enhanced ultrasound (CEUS) using Definity microbubbles to the surgeon's usual approach during glioma resection. Adult patients with a planned standard-of-care craniotomy for presumed primary or recurrent glioma and WHO performance status ≤2 may receive CEUS imaging during their operation. The procedure is performed in the operating room and images are used to guide visualization of tumor margins while safety (including allergic reactions and infection risk) is monitored. The study is conducted at the University of Colorado Anschutz Medical Campus and focuses on feasibility and imaging utility rather than randomized comparison.
Who should consider this trial
Good fit: Adults aged 18–95 who are scheduled for standard surgical resection of a presumed primary or recurrent glioma, able to consent, with WHO performance status ≤2 (KPS ≥70) and negative pregnancy test if applicable are ideal candidates.
Not a fit: Patients with known hypersensitivity to perflutren (Definity), active or chronic infections, high surgical-site infection risk, or those not undergoing resection are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, CEUS could help surgeons remove more tumor while better preserving normal brain, which may reduce residual disease and improve clinical outcomes.
How similar studies have performed: Small case series and pilot studies of intraoperative CEUS for brain tumors have shown promising improvements in tumor visualization, but larger controlled trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: D. Ryan Ormond, MD PhD — University of Colorado, Denver
- Study coordinator: Jen Maitlen, BSN
- Email: jennifer.maitlen@cuanschutz.edu
- Phone: 303-724-1995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioma in the Brain, Glioma, brain tumor, resection, glioma