Wearable fluorescence imaging for brain tumor surgery
Official title: Loupe-Based Intraoperative Fluorescence Imaging for the Guidance of Brain Tumor Surgery
Run by University of Kentucky · NCT04780009 · Data updated 2026-11-12
This study is testing a new wearable device that uses special light to help surgeons find brain tumors during surgery, comparing it to a traditional microscope to see if it works just as well.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | November 17, 2017 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT04780009 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with malignant gliomas scheduled for surgical resection.
✕Probably not a fit
Patients undergoing emergency surgery or those unable to provide consent due to language barriers or dysphagia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the accuracy of a wearable loupe-based fluorescence imaging device compared to a large operative microscope in identifying tumor tissues during surgery for glioblastoma multiforme and anaplastic astrocytoma. Patients will receive intravenous sodium 5-aminolevulinic acid or fluorescein before surgery, which will be performed under fluorescence guidance. The study will involve biopsying tumor resection margins to assess the accuracy of both imaging systems against histopathological analysis. The goal is to develop a low-cost, easy-to-use device that provides similar accuracy to traditional methods.
Why it matters
Potential benefit: If successful, this device could enhance the precision of brain tumor resections, potentially improving patient outcomes and survival rates.
How similar studies have gone: While similar imaging techniques have been explored, this specific approach using a loupe-based device is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * adults with brain malignant gliomas undergoing resection * at least 18 years of age * able to understand the consent Exclusion Criteria: * pregnant women * under 18 years of age * patients undergoing emergency surgery * inability to give consent due to dysphagia or language barrier
Where it's running
-
University of Kentucky
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Guoqiang Yu, PhD — University of Kentucky
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.