Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sonobiopsy
DeviceUltrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy
Research blood
Procedure/SurgeryNo 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
GeneticCancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.
Definity®
DeviceBeing used off-label in this trial
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: SonobiopsyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 12
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.
Time frame
Day 1Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov