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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

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