Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Glioblastoma Clinical Trial

Official title:

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281731
• Other study ID #: 202202025
• Secondary ID: R01CA276174
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Albert Kim, M.D.
• Phone: 314-747-6561
• Email: alberthkim[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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

Procedure:
• Research blood
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)

Genetic:
• Cancer Personalized Profiling
Cancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.

Device:
• Definity®
Being used off-label in this trial

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	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.	Day 1

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine