Investigational Imaging Technique During Brain Surgery
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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To characterize the biophysical and structural features that enable detection of bulk tumor and tumor margins, including infiltrative disease, with qOBM.
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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 Design
Arms and Interventions
| 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:
Device: Quantitative Oblique Back-Illumination Microscopy
Undergo intraoperative microscopy utilizing qOBM
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events [Up to 3 years]
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 [Up to 3 years]
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. Patient demographics will be summarized descriptively. 95% confidence intervals will be reported, unless otherwise specified. All tests will be two-sided.
Secondary Outcome Measures
- Collection of Descriptive data on the Performance of the Quantitative Oblique Back Illumination Microscopy [Up to 3 years]
Robustness will be defined as the device's ability to quantitatively assess image features to guide neurosurgery. This will be achieved by training a classifier (using quantitative image features and training a support vector machine or using deep neural networks) and then testing the classifier using images taken in-situ and in-vivo from tissues that were later resected. A link between the device's images and ground truth will be made by analyzing and comparing histological data using hematoxylin and eosin-stained tissue sections from approximately the same regions. Summary statistics will be reported for categorical variables using frequencies and percentages, and for continuous 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.
- Development of Quantitative Oblique Back Illumination Microscopy imaging probes with Multimodal Capabilities [Up to 3 years]
Robustness is defined again as the device's ability to clearly reveal relevant cellular and subcellular histological structures that can lead to clinically actionable outcomes. Summary statistics will be reported using descriptive statistics. Patient demographics will be summarized descriptively. 95% confidence intervals will be reported, unless otherwise specified. All tests will be two-sided.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >= 18 years
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Craniotomy is indicated for tumor management
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Surgery planned for 14 or fewer days from enrollment
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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.
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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:
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Patients who are undergoing needle biopsy only
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jeffrey J. Olson, MD, Emory University Hospital/Winship Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00004168
- NCI-2022-06212
- STUDY00004168
- WINSHIP5571-22
- P30CA138292