Actively Recruiting

Age: 18Years - 90Years
All Genders
NCT04780009

Loupe-Based Intraoperative Fluorescence Imaging

Led by Guoqiang Yu · Updated on 2025-07-09

30

Participants Needed

1

Research Sites

445 weeks

Total Duration

On this page

Sponsors

G

Guoqiang Yu

Lead Sponsor

B

Bioptics Technology LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections. This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.

CONDITIONS

Official Title

Loupe-Based Intraoperative Fluorescence Imaging

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with brain malignant gliomas undergoing tumor resection
  • At least 18 years of age
  • Able to understand and provide consent
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Under 18 years of age
  • Patients undergoing emergency surgery
  • Unable to give consent due to swallowing difficulties or language barriers

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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