Loupe-Based Intraoperative Fluorescence Imaging

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Guoqiang Yu
Study ID
NCT04780009
Status
Recruiting
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Conditions

  • Anaplastic Astrocytoma
  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 17, 2017
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Positive Predictive Value (PPV) [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Thomas Pittman, MD
[email protected]
859-323-8986
Thomas Pittman, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kentucky· Lexington, KY

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