Towards In-Vivo, Intraoperative Image Guided Brain Tumor Margin Assessment With Quantitative Oblique Back Illumination Microscopy
Trial ID: NCT05513859
Interventional - Phase Unknown - Suspended
This early phase I 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 be able to assess and reveal brain tumor surgical margins in a more safe and reliable manner.
Conditions
Astrocytoma
Glioblastoma
Oligodendroglioma
Interventions
Craniotomy
Quantitative Oblique Back-Illumination Microscopy
Eligibility
Inclusion criteria
- Age >= 18 years
Craniotomy is indicated for tumor management
Surgery planned for 14 or fewer days from enrollment
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the device evaluation, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
A newly discovered brain lesion requiring surgery who imaging is consistent with a new glioblastoma, astrocytoma, or oligodendroglioma or with a progressive histologically proven glioblastoma, astrocytoma, or oligodendroglioma whose management required surgery.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
Patients who are undergoing needle biopsy only
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.