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Ultrasound

Sonobiopsy for Glioblastoma

N/A
Recruiting
Led By Albert Kim, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be at least 18 years old
Must be planning to undergo surgical resection of the tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study Summary

This trial is important because it will help doctors understand how to best treat brain tumors by looking at their molecular features. Sonobiopsy has the potential to become a standard tool for diagnosing and managing brain tumors, which could dramatically improve patient outcomes.

Who is the study for?
This trial is for adults with a new diagnosis of glioblastoma, where the tumor is larger than 3 cm and close to the brain's surface. Candidates must be planning surgery to remove the tumor and have not had previous cancer treatments or cranial surgeries. People with MRI contraindications, skin diseases affecting ultrasound use, coagulopathy, metal in their head, or unstable heart/lung conditions cannot join.Check my eligibility
What is being tested?
The study tests sonobiopsy—a noninvasive method that could help doctors understand brain tumors better by regularly collecting genetic and molecular information without surgery. This could lead to personalized treatment plans aimed at improving survival and life quality.See study design
What are the potential side effects?
While specific side effects are not listed for sonobiopsy, potential risks may include discomfort during the procedure, minor bleeding or bruising at the probe site on the scalp, allergic reactions to contrast agents used in imaging like Definity®, or rare complications from sedation if required.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for surgery to remove my tumor.
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My brain lesion is near the surface and in the upper part of my brain.
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My cancer is low grade or has spread to other parts of my body.
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My brain tumor has come back or I have tissue damage from radiation.
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My lesion lights up with a special dye in MRI scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of sonobiopsy as measured by change in ctDNA level
Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample

Trial Design

1Treatment groups
Experimental Treatment
Group I: SonobiopsyExperimental Treatment4 Interventions
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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,307 Total Patients Enrolled
316 Trials studying Glioblastoma
22,628 Patients Enrolled for Glioblastoma
Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,923 Total Patients Enrolled
17 Trials studying Glioblastoma
581 Patients Enrolled for Glioblastoma
Albert Kim, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

Sonobiopsy (Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05281731 — N/A
Glioblastoma Research Study Groups: Sonobiopsy
Glioblastoma Clinical Trial 2023: Sonobiopsy Highlights & Side Effects. Trial Name: NCT05281731 — N/A
Sonobiopsy (Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05281731 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently taking part in this research study?

"Affirmative. The clinicaltrial.gov registry states that this research program is actively seeking participants and was first listed on April 16th 2022. To date, the trial has enrolled 20 individuals at a single medical center."

Answered by AI

Is enrollment in this experiment ongoing?

"Confirmation of active recruitment is available on clinicaltrials.gov; this trial was initially made public on April 16th 2022 and the most recent update occurred September 21st of the same year."

Answered by AI
~14 spots leftby Apr 2025