Noninvasive detection of glioblastoma using sonobiopsy
Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
This study is testing a new noninvasive method called sonobiopsy to see if it can help doctors better detect and understand glioblastoma in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05281731 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the use of sonobiopsy to enhance the detection and characterization of glioblastoma by acquiring tumor genetic and molecular signatures noninvasively. The approach aims to complement existing diagnostic methods such as imaging and surgical histology, potentially improving treatment personalization and patient outcomes. By providing a third pillar in brain tumor management, sonobiopsy could significantly impact the understanding of tumor biology and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are adults newly diagnosed with glioblastoma multiforme who are planning to undergo surgical resection of the tumor.
Not a fit: Patients with contraindications to MRI, previous cranial surgery, or a history of other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with glioblastoma.
How similar studies have performed: While the concept of sonobiopsy is innovative, similar noninvasive approaches have shown promise in other contexts, suggesting potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be newly diagnosed with a lesion in the brain with imaging characteristics consistent with glioblastoma multiforme. Scan must have occurred no more than 28 days prior to enrollment. * Lesion must be \> 3 cm in maximal dimension on MRI. * Lesion must be in the supratentorial space within 5 cm of the cortical surface. * Lesion must be gadolinium enhancing. * Low grade tumors and metastatic tumors * Recurrent brain tumors and/or radiation necrosis * Must be planning to undergo surgical resection of the tumor. * Must be at least 18 years old. * Patients with recurrent GBM who are planning to undergo surgical resection or laser ablation of the recurrent tumor. Recurrence must be confirmed on MRI performed no more than 28 days prior to enrollment. Exclusion Criteria: * Contraindication to MRI. * Previous cranial surgery. * Previous history of cancer and/or cancer treatments. * Coagulopathy within 14 days of enrollment defined as PT/PTT outside of normal parameters and platelets \< 100,000/mcL. * Physical skull defect of any kind. * Ferrous material in the scalp or skull. * Scalp or skin disease that limits contact with the ultrasound probe. * Enrolled in another clinical trial where intervention is administered prior to surgery. * Known hypersensitivity to polyethylene glycol. * Known unstable cardiopulmonary condition (e.g. acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias).
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Albert Kim, M.D. — Washington University School of Medicine
- Study coordinator: Albert Kim, M.D.
- Email: alberthkim@wustl.edu
- Phone: 314-747-6561
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.