NCT05281731 Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
| NCT ID | NCT05281731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-04-18 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. * 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).
Contact & Investigator
Albert Kim, M.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05281731 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05281731 currently recruiting?
Yes, NCT05281731 is actively recruiting participants. Contact the research team at alberthkim@wustl.edu for enrollment information.
Where is the NCT05281731 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05281731 clinical trial?
NCT05281731 is sponsored by Washington University School of Medicine. The principal investigator is Albert Kim, M.D. at Washington University School of Medicine. The trial plans to enroll 40 participants.
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