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Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05281731
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Albert Kim, M.D.
Principal Investigator Affiliation Washington University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Glioblastoma Multiforme
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Sonobiopsy

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Albert Kim, M.D.

[email protected]

314-747-6561

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