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Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Primary Purpose

Glioblastoma, Glioblastoma Multiforme

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sonobiopsy

Research blood

Cancer Personalized Profiling

Definity®

About this trial

This is an interventional other trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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).

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sonobiopsy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05281731

First Posted

February 11, 2022

Last Updated

May 25, 2023

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05281731

Brief Title

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Official Title

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Glioblastoma Multiforme

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sonobiopsy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Sonobiopsy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Research blood

Intervention Description

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)

Intervention Type

Genetic

Intervention Name(s)

Cancer Personalized Profiling

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Definity®

Other Intervention Name(s)

Definity® microbubbles

Intervention Description

Being used off-label in this trial

Primary Outcome Measure Information:

Title

Feasibility of sonobiopsy as measured by change in ctDNA level

Description

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 1

Title

Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample

Description

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 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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. 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Albert Kim, M.D.

Phone

314-747-6561

alberthkim@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert Kim, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Albert Kim, M.D.

Phone

314-747-6561

alberthkim@wustl.edu

First Name & Middle Initial & Last Name & Degree

Albert Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Eric Leuthardt, M.D.

First Name & Middle Initial & Last Name & Degree

Hong Chen, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.siteman.wustl.edu

Description

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

Learn more about this trial

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

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