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Spots Global Cancer Trial Database for Investigational Imaging Technique During Brain Surgery

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Trial Identification

Brief Title: Investigational Imaging Technique During Brain Surgery

Official Title: Towards In-Vivo, Intraoperative Image Guided Brain Tumor Margin Assessment With Quantitative Oblique Back Illumination Microscopy

Study ID: NCT05513859

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Contact Details

Name: Jeffrey J. Olson, MD

Affiliation: Emory University Hospital/Winship Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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