GlioblastomaNCT05281731
Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
A study testing Sonobiopsy, Research blood and Cancer Personalized Profiling in people with Glioblastoma and Glioblastoma Multiforme, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- Sonobiopsy, Research blood and Cancer Personalized Profiling
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Albert Kim, M.D., 314-747-6561, alberthkim@wustl.edu
Albert Kim, M.D.
About this study
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.
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Being tested
- Sonobiopsy, Research blood, Cancer Personalized Profiling, Definity®
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonobiopsyDevice
Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy
Research bloodProcedure or surgery
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 ProfilingGenetic
Cancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.
Definity®Device
Also called Definity® microbubbles
Being used off-label in this trial
| Study group | Role | What they receive |
|---|---|---|
| Sonobiopsy | Experimental | * Once enrolled, participants would be prepared for standard of care surgery.
* The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur.
* An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2* sequence.
* Blood will be collected at several time points.
* A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor.
* The blood, tumor, and skin (if applicable) will undergo genetic analysis. Receives: Device: Sonobiopsy; Procedure: Research blood; Genetic: Cancer Personalized Profiling; Device: Definity® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of sonobiopsy as measured by change in ctDNA level
The feasibility of sonobiopsy will be demonstrated by an increase in the amount of ctDNA in the blood samples acquired post than prior sonobiopsy in at least 50% of the patients.
Measured: Day 1
Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample
The agreement of the post-sonobiopsy sample mutation detected in the blood with a variant identified in the tumor tissue will be compared using a kappa statistic.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start18 Apr 2022
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Albert Kim, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281731
- Sponsor's protocol ID
- 202202025
- Other IDs
- R01CA276174
- Status last verified
- May 2026
- First submitted
- 11 Feb 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
- ClinicalTrials.gov ID
- NCT05281731
- Acronym / sponsor ID
- 202202025
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonobiopsy | Experimental | Device: Sonobiopsy, Procedure: Research blood, Genetic: Cancer Personalized Profiling, Device: Definity®* Once enrolled, participants would be prepared for standard of care surgery. * The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur. * An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2* sequence. * Blood will be collected at several time points. * A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor. * The blood, tumor, and skin (if applicable) will undergo genetic analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonobiopsyUltrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy | Device | Sonobiopsy |
| Research bloodNo 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) | Procedure or surgery | Sonobiopsy |
| Cancer Personalized ProfilingCancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy. | Genetic | Sonobiopsy |
| Definity®Also: Definity® microbubblesBeing used off-label in this trial | Device | Sonobiopsy |
Primary outcome
Feasibility of sonobiopsy as measured by change in ctDNA level
Time frame: Day 1
The feasibility of sonobiopsy will be demonstrated by an increase in the amount of ctDNA in the blood samples acquired post than prior sonobiopsy in at least 50% of the patients.
Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample
Time frame: Day 1
The agreement of the post-sonobiopsy sample mutation detected in the blood with a variant identified in the tumor tissue will be compared using a kappa statistic.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert Kim, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonobiopsy, Research blood and Cancer Personalized Profiling in people with Glioblastoma and Glioblastoma Multiforme, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Kim, M.D. (314-747-6561, alberthkim@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of sonobiopsy as measured by change in ctDNA level (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.