Investigational Imaging Technique During Brain Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05513859
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emory University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jeffrey J. Olson, MD
Principal Investigator Affiliation	Emory University Hospital/Winship Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Astrocytoma, Glioblastoma, Oligodendroglioma

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Procedure: - Craniotomy

Undergo craniotomy

Device: - Quantitative Oblique Back-Illumination Microscopy

Undergo intraoperative microscopy utilizing qOBM

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Atlanta, Georgia

Status

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Site Contact

Agnes Harutyunyan

[email protected]

404-778-4389

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