This clinical trial tests the safety and reliability of an investigational imaging technique called quantitative oblique back illumination microscopy (qOBM) during brain surgery for detecting brain tumors and brain tumor margins in patients with glioblastoma, astrocytoma, or oligodendroglioma. Surgical margins refer to the edge or border of the tissue removed in cancer surgery. qOBM may assist doctors in detecting brain tumor and its margins with surrounding normal tissue more safely and reliably in patients with glioblastoma, astrocytoma, or oligodendroglioma.
Additional locations may be listed on ClinicalTrials.gov for NCT05513859.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Jeffrey J. Olson
Phone: 404-778-3091
PRIMARY OBJECTIVE:
I. To perform a first-in-human study to assess the ability of a device that utilizes quantitative oblique back illumination microscopy (qOBM) technology to safely and reliably image brain tumor pathology intraoperatively in-situ and in-vivo.
SECONDARY OBJECTIVES:
I. To characterize the biophysical and structural features that enable detection of bulk tumor and tumor margins, including infiltrative disease, with qOBM.
II. To develop qOBM imaging systems with multimodal capabilities (analog black and white and color imaging, fluorescent imaging) and with the potential to clearly reveal brain tumor margins ex vivo and in vivo during neurosurgical procedures.
OUTLINE:
Patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment with qOBM. Patients then undergo postoperative exam with computed tomography (CT) or magnetic resonance imaging (MRI) any of days 1-5 after surgery.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorJeffrey J. Olson