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Trial Title:
Investigational Imaging Technique During Brain Surgery
NCT ID:
NCT05513859
Condition:
Astrocytoma
Glioblastoma
Oligodendroglioma
Conditions: Official terms:
Glioblastoma
Astrocytoma
Oligodendroglioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Craniotomy
Description:
Undergo craniotomy
Arm group label:
Diagnostic (qOBM)
Other name:
Open Craniotomy
Intervention type:
Device
Intervention name:
Quantitative Oblique Back-Illumination Microscopy
Description:
Undergo intraoperative microscopy utilizing qOBM
Arm group label:
Diagnostic (qOBM)
Other name:
qOBM
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Agnes Harutyunyan
Phone:
404-778-4389
Email:
agnieszka.anna.harutyunyan@emory.edu
Investigator:
Last name:
Jeffrey J. Olson, MD
Email:
Principal Investigator
Start date:
October 30, 2024
Completion date:
June 23, 2025
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513859