Loupe-Based Intraoperative Fluorescence Imaging

NCT04780009 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-07-09

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • Bioptics Technology LLC

    collaborator UNKNOWN
  • National Cancer Institute (NCI)

    collaborator NIH
  • Kentucky Small Business Innovation Research / Small Business Technology Transfer (SBIR/STTR)

    collaborator UNKNOWN
  • Guoqiang Yu

    lead OTHER

Principal Investigators

  • Guoqiang Yu, PhD · University of Kentucky

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780009 on ClinicalTrials.gov