An Investigational Imaging Technique (Quantitative Oblique Back Illumination Microscopy) during Brain Surgery for the Detection of Brain Tumors and Brain Tumor Margins

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Brain Tumor	NCT ID:	NCT05513859
Trial Phases:		Protocol IDs:	WINSHIP5571-22 (primary) NCI-2022-06212 STUDY00004168
Eligibility:	18 Years and older, Male and Female	Study Type:	Diagnostic
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05513859

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 assist doctors in detecting brain tumor and its margins with surrounding normal tissue more safely and reliably in patients with glioblastoma, astrocytoma, or oligodendroglioma.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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