NCT05281731Recruiting
Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Feb 2022
- Start date
- 18 Apr 2022
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Glioblastoma
- NCT number
- NCT05281731
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 18 Apr 2022 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cranial surgery.
- Enrolled in another clinical trial where intervention is administered prior to surgery.
Other illness
- Previous history of cancer and/or cancer treatments.
- Scalp or skin disease that limits contact with the ultrasound probe.
- 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).
Lab values
- Coagulopathy within 14 days of enrollment defined as PT/PTT outside of normal parameters and platelets \< 100,000/mcL.
Other
- Contraindication to MRI.
- Physical skull defect of any kind.
- Ferrous material in the scalp or skull.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.