Wearable fluorescence imaging for brain tumor surgery
Loupe-Based Intraoperative Fluorescence Imaging for the Guidance of Brain Tumor Surgery
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04780009 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with malignant gliomas scheduled for surgical resection.
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.
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 performed: While similar imaging techniques have been explored, this specific approach using a loupe-based device is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Guoqiang Yu, PhD — University of Kentucky
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.