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NCT Number: NCT05281731

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Albert Kim, M.D.

CONTACT

[email protected]

314-747-6561

Albert Kim, M.D.

PRINCIPAL_INVESTIGATOR

Eric Leuthardt, M.D.

SUB_INVESTIGATOR

Hong Chen, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sonobiopsy

Device

Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy

Research blood

Procedure

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

Genetic

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

Being used off-label in this trial

Other names: Definity® microbubbles

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Kim, M.D.

CONTACT

[email protected]

314-747-6561

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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