NCT05513859

Investigational Imaging Technique During Brain Surgery

Towards In-Vivo, Intraoperative Image Guided Brain Tumor Margin Assessment With Quantitative Oblique Back Illumination Microscopy

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To perform a first-in-human study to assess the ability of a quantitative oblique back illumination microscopy (qOBM) handheld device 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 probes 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.

Conditions

• Astrocytoma
• Glioblastoma
• Oligodendroglioma

Interventions

Type	Name	Description
PROCEDURE	Craniotomy	Undergo craniotomy
DEVICE	Quantitative Oblique Back-Illumination Microscopy	Undergo intraoperative microscopy utilizing qOBM

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-06-28
• Completion: 2027-06-23
• First posted: 2022-08-24
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study