Investigational Imaging Technique During Brain Surgery

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

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.

Study Overview

• Status: Suspended
• Conditions: Glioblastoma; Astrocytoma; Oligodendroglioma
• Intervention / Treatment: Procedure: Craniotomy; Device: Quantitative Oblique Back-Illumination Microscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (qOBM); Patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment with qOBM. Patients then undergo postoperative exam with CT or MRI any of days 1-5 after surgery.	Procedure: Craniotomy; Undergo craniotomy; Other Names: Open Craniotomy; Device: Quantitative Oblique Back-Illumination Microscopy; Undergo intraoperative microscopy utilizing qOBM; Other Names: qOBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events version 5.0. Summary statistics will be reported for categorical variables using descriptive statistics. Patient demographics will be summarized descriptively. 95% confidence intervals will be reported, unless otherwise specified. All tests will be two-sided.	Up to 3 years
Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Frequency Distribution	Robustness will be defined as the device's ability to clearly reveal relevant cellular and subcellular histological structures that can lead to clinically actionable outcomes, is determined. Using standard clinical techniques such as loupe magnification, surgical microscopy, histology, intraoperative ultrasound, and postoperative magnetic resonance imaging (MRI) as general points of historical reference. Summary statistics will be reported for categorical variables using descriptive statistics measures of frequency. Patient demographics will be summarized descriptively. All tests will be two-sided.	Up to 3 years
Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Standard Deviation	Robustness will be defined as the device's ability to clearly reveal relevant cellular and subcellular histological structures that can lead to clinically actionable outcomes, is determined. Using standard clinical techniques such as loupe magnification, surgical microscopy, histology, intraoperative ultrasound, and postoperative magnetic resonance imaging (MRI) as general points of historical reference. Summary statistics will be reported for categorical variables using standard deviation.Patient demographics will be summarized descriptively. 95% confidence intervals will be reported, unless otherwise specified. All tests will be two-sided.	Up to 3 years
Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Central Tendency	Robustness will be defined as the device's ability to clearly reveal relevant cellular and subcellular histological structures that can lead to clinically actionable outcomes, is determined. Using standard clinical techniques such as loupe magnification, surgical microscopy, histology, intraoperative ultrasound, and postoperative magnetic resonance imaging (MRI) as general points of historical reference. Summary statistics will be reported for categorical variables using descriptive statistics measures of central tendency. Patient demographics will be summarized descriptively. 95% confidence intervals will be reported, unless otherwise specified. All tests will be two-sided.	Up to 3 years
Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Measures of Position	Robustness will be defined as the device's ability to clearly reveal relevant cellular and subcellular histological structures that can lead to clinically actionable outcomes, is determined. Using standard clinical techniques such as loupe magnification, surgical microscopy, histology, intraoperative ultrasound, and postoperative magnetic resonance imaging (MRI) as general points of historical reference. Summary statistics will be reported for categorical variables using descriptive statistics interquartile range. Patient demographics will be summarized descriptively. 95% confidence intervals will be reported, unless otherwise specified. All tests will be two-sided.	Up to 3 years

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kimberly J. Hoang, MD, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 23, 2028

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Astrocytoma; Oligodendroglioma; Surgical Procedures, Operative; Neurosurgical Procedures; Craniotomy
• Other Study ID Numbers: STUDY00004168 (Other Identifier: Emory University Hospital/Winship Cancer Institute); P30CA138292 (U.S. NIH Grant/Contract); NCI-2022-06212 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); WINSHIP5571-22 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No