Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
Washington University School of Medicine
40 participants
Apr 18, 2022
INTERVENTIONAL
Conditions
Summary
This clinical study to evaluate sonobiopsy is significant because sonobiopsy will fundamentally enhance the clinician's insight into the molecular features of an intracranial lesion to tailor treatment approaches and optimize outcomes. In addition to the standard diagnostics of anatomic imaging and surgical histology, sonobiopsy has the potential to become the third pillar for brain tumor management by radically advancing the ability to easily and regularly acquire tumor genetic and molecular signatures. This enhanced capability will have a dramatic impact on patient survival and quality of life.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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).
Interventions
Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy
No more than 10 minutes prior to ultrasound sonication, 10 minutes after ultrasound sonication, 30 minutes after ultrasound sonication (optional at the discretion of the PI), and 60 minutes after ultrasound sonication (optional at the discretion of the PI)
Cancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.
Being used off-label in this trial
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05281731