Investigational Imaging Technique During Brain Surgery

Emory University

Status: Suspended

Conditions: Oligodendroglioma; Glioblastoma; Astrocytoma

Treatments: Procedure: Craniotomy; Device: Quantitative Oblique Back-Illumination Microscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05513859

NCI-2022-06212 (Registry Identifier)

P30CA138292 (U.S. NIH Grant/Contract)

STUDY00004168 (Other Identifier)

WINSHIP5571-22 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Diagnostic (qOBM)

Experimental group

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.

Treatment:

Device: Quantitative Oblique Back-Illumination Microscopy

Procedure: Craniotomy