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Investigational Imaging Technique During Brain Surgery

Primary Purpose

Astrocytoma, Glioblastoma, Oligodendroglioma

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Craniotomy

Quantitative Oblique Back-Illumination Microscopy

About this trial

This is an interventional diagnostic trial for Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Emory University Hospital/Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (qOBM)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05513859

First Posted

August 22, 2022

Last Updated

July 3, 2023

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05513859

Brief Title

Investigational Imaging Technique During Brain Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 11, 2023 (Anticipated)

Primary Completion Date

June 23, 2025 (Anticipated)

Study Completion Date

June 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astrocytoma, Glioblastoma, Oligodendroglioma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (qOBM)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Craniotomy

Other Intervention Name(s)

Open Craniotomy

Intervention Description

Undergo craniotomy

Intervention Type

Device

Intervention Name(s)

Quantitative Oblique Back-Illumination Microscopy

Other Intervention Name(s)

qOBM

Intervention Description

Undergo intraoperative microscopy utilizing qOBM

Primary Outcome Measure Information:

Title

Incidence of Adverse Events

Description

Time Frame

Up to 3 years

Title

Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Frequency Distribution

Description

Time Frame

Up to 3 years

Title

Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Standard Deviation

Description

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.

Time Frame

Up to 3 years

Title

Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Central Tendency

Description

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.

Time Frame

Up to 3 years

Title

Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Measures of Position

Description

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.

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey J. Olson, MD

Phone

404-778-5770

jolson@emory.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Francisco E. Robles, PhD

Phone

404-385-2989

francisco.robles@bme.gatech.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey J. Olson, MD

Organizational Affiliation

Emory University Hospital/Winship Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital/Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnes Harutyunyan

Phone

404-778-4389

agnieszka.anna.harutyunyan@emory.edu

First Name & Middle Initial & Last Name & Degree

Jeffrey J. Olson, MD

12. IPD Sharing Statement

Learn more about this trial

Investigational Imaging Technique During Brain Surgery

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