Status:
RECRUITING
Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioblastoma
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05281731
Start Date
April 18 2022
End Date
November 30 2028
Last Update
October 28 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110