Clinical trial NCT05281731: Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
Official title: Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Glioblastoma Multiforme
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 criteria: 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).

Primary outcomes:
measure: Feasibility of sonobiopsy as measured by change in ctDNA level
timeFrame: Day 1
measure: Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Albert Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: