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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 95 Years
Gender	All

More 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 /= 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07050836
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	D. Ryan Ormond, MD PhD
Principal Investigator Affiliation	University of Colorado, Denver
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma (Any Grade) in the Brain, Glioma

Arms & Interventions

Arms

Experimental: Brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound

Interventions

Combination Product: - Definity 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora 5412347, Colorado 5417618

Status

Address

University of Colorado Anschutz Medical Campus

Aurora 5412347, Colorado 5417618, 80045

Site Contact

Jennifer Maitlen, BSN

[email protected]

303-724-1995

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