RECRUITING

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

Quick Facts

Study Start:2022-04-18
Study Completion:2028-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05281731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Lesion must be \> 3 cm in maximal dimension on MRI.
  3. * Lesion must be in the supratentorial space within 5 cm of the cortical surface.
  4. * Lesion must be gadolinium enhancing.
  5. * Low grade tumors and metastatic tumors
  6. * Recurrent brain tumors and/or radiation necrosis
  7. * Must be planning to undergo surgical resection of the tumor.
  8. * Must be at least 18 years old.
  9. * 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.
  1. * Contraindication to MRI.
  2. * Previous cranial surgery.
  3. * Previous history of cancer and/or cancer treatments.
  4. * Coagulopathy within 14 days of enrollment defined as PT/PTT outside of normal parameters and platelets \< 100,000/mcL.
  5. * Physical skull defect of any kind.
  6. * Ferrous material in the scalp or skull.
  7. * Scalp or skin disease that limits contact with the ultrasound probe.
  8. * Enrolled in another clinical trial where intervention is administered prior to surgery.
  9. * Known hypersensitivity to polyethylene glycol.
  10. * Known unstable cardiopulmonary condition (e.g. acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias).

Contacts and Locations

Study Contact

Albert Kim, M.D.
CONTACT
314-747-6561
alberthkim@wustl.edu

Principal Investigator

Albert Kim, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Albert Kim, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-18
Study Completion Date2028-11-30

Study Record Updates

Study Start Date2022-04-18
Study Completion Date2028-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Glioblastoma
  • Glioblastoma Multiforme