Contrast Enhanced Ultrasound for Brain Cancer

Overseen By Terra Ornelas, BSN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Disqualifiers: Infections, Cardiac disease, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve brain tumor surgeries using contrast-enhanced ultrasound (CEUS). The goal is to assist surgeons in visualizing and removing more of the glioma tumor by using Definity, a special contrast agent, during surgery. Suitable candidates for this trial include those planning surgery for a primary or recurrent glioma brain tumor. Participants must be willing to follow all study procedures and have no known allergies to the contrast agent. As an Early Phase 1 trial, this research aims to understand how this new technique works in people, offering participants the chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for brain tumor surgery?

Research has shown that Definity, used in contrast-enhanced ultrasound (CEUS), is generally well-tolerated. It effectively improves ultrasound images, particularly in brain surgery. While detailed safety information is still being collected, the treatment uses tiny bubbles to enhance images. These bubbles are designed to be safe and naturally dissolve in the body without causing harm.

In other applications, Definity has been used for imaging, and no major safety issues have been reported. However, since this study is in its early stages, it primarily focuses on gathering more information about safety and effectiveness. Early results are promising, but more research is needed to fully understand any potential risks. Participants can feel reassured that the treatment has undergone previous testing and is being studied further to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, Definity offers a unique approach by enhancing imaging capabilities through contrast-enhanced ultrasound. Researchers are excited about Definity because it uses microbubbles to improve the visibility of blood vessels and tumors during ultrasound scans, potentially leading to more precise surgical outcomes. This novel method could allow doctors to more accurately identify and target tumor tissue, which might improve the effectiveness of surgeries and reduce the risk of leaving cancerous cells behind.

What evidence suggests that using contrast enhanced ultrasound is effective for brain tumor surgery?

Research has shown that contrast-enhanced ultrasound (CEUS) with Definity can assist in brain tumor surgeries. In this trial, participants will undergo brain tumor surgery using Definity contrast and CEUS. Definity, a special dye, helps make tumor tissue stand out more clearly. Earlier studies have used it to temporarily open the blood-brain barrier, the protective layer around the brain, to deliver medication directly to tumors. When combined with focused ultrasound, this method has shown potential in helping doctors see and target tumors more effectively. Although limited data exist from human studies, these findings suggest that CEUS might help surgeons remove more of the tumor by improving visibility. This is particularly important for tumors like gliomas, which can be difficult to distinguish from healthy brain tissue. ^{1 2 5 6 7}

Who Is on the Research Team?

D. Ryan Ormond, MD PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals undergoing surgery for glioma brain tumors. It aims to help surgeons better distinguish tumor tissue from normal brain tissue during the operation.

Inclusion Criteria

Able to sign and date the consent form

Patient of childbearing potential must have a negative pregnancy test within 14 days of inclusion

I am willing and able to follow the study rules and attend all required visits.

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

Pregnant, or breastfeeding patient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Participants undergo brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound to improve tumor visualization

Up to 3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Definity

Trial Overview The study is testing whether using a contrast agent called Definity during ultrasound can improve visualization and border demarcation of gliomas in brain surgeries.

How Is the Trial Designed?

Group I: Brain tumor surgery with Definity contrast and Contrast Enhanced Ultrasound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11538134/

Focused ultrasound-mediated enhancement of blood– ... Brain tumors continue to exhibit a poor prognosis, with less than 20% of patients surviving beyond 5 years post-diagnosis [1]. Glioblastoma ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07179328

NCT07179328 | Focused Ultrasound Blood-Brain Barrier ... It is used to disrupt the blood-brain barrier (BBB) in patients with glioblastoma during the maintenance phase of temozolomide (TMZ) therapy.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2950195424001437

Ultrasound mediated blood-brain barrier opening ... This technique, termed sonobiopsy, enables non-invasive biomarker collection for liquid biopsy, potentially improving brain tumor diagnosis and monitoring.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2066193/

Use of ultrasound pulses combined with Definity® for ... The purpose of this work was to test the feasibility of using the contrast agent Definity® for BBBD. Thirty-six non-overlapping locations were sonicated through ...

5. nature.com nature.com/articles/s41598-025-88379-5

Evaluation of blood-tumor barrier permeability and ... This novel FUS approach offers a promising, cost-effective strategy for enhancing drug delivery to brain tumors.

6. nature.com nature.com/articles/s41598-018-35677-w

Safety evaluation of frequent application of microbubble ... This study examines whether frequent focused ultrasound blood brain barrier opening is associated with aggravated behavioral, histopathologic change or brain ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9959315/

Microbubble Delivery Platform for Ultrasound-Mediated ... This review describes a state-of-the-art strategy for fabricating MB-based delivery platforms and their use with ultrasound in brain cancer therapy.