Investigational Imaging Technique During Brain Surgery

NCT05513859 | Suspended DMC FDA Device

• 4 other identifiers: STUDY00004168NCI-2022-06212WINSHIP5571-22P30CA138292
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Astrocytoma; Glioblastoma; Oligodendroglioma

Outcome Measures

Primary Outcomes (5)

• 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histology, intraoperative ultrasound, and postoperative magnetic resonance imaging (MRI) as general points of historical reference.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

Study Arms (1)

Diagnostic (qOBM)

EXPERIMENTAL

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; Device: Quantitative Oblique Back-Illumination Microscopy

Interventions

Craniotomy PROCEDURE

Undergo craniotomy

Also known as: Open Craniotomy

Diagnostic (qOBM)

Quantitative Oblique Back-Illumination Microscopy DEVICE

Undergo intraoperative microscopy utilizing qOBM

Also known as: qOBM

Diagnostic (qOBM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Oligodendroglioma

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Kimberly J. Hoang, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: March 11, 2024
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 23, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)