Loupe-Based Intraoperative Fluorescence Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorGuoqiang Yu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults with brain malignant gliomas undergoing resection
at least 18 years of age
able to understand the consent
Disqualifiers
pregnant women
under 18 years of age
patients undergoing emergency surgery
inability to give consent due to dysphagia or language barrier
Trial population
Patients undergoing glioblastoma multiforme and anaplastic astrocytoma resection recruited from the University of Kentucky Multidisciplinary Oncology Clinic (UK-MOC).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Positive Predictive Value (PPV)
The proportion of samples that are histologically confirmed as tumor-positive among all fluorescent samples will be calculated.
Time frame
1 day2
Negative Predictive Value (NPV)
The proportion of samples that are histologically confirmed as tumor-negative among all fluorescent samples will be calculated.
Time frame
1 daySecondary outcomes
1
Residual Tumor
The proportion of positive results among all tumors with residual as well as the proportion of negative results among tumors without residual will be calculated relative to post-operative histopathological analysis.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Guoqiang Yu
Lead sponsor
University of Kentucky
Sponsor institution
Bioptics Technology LLC
Collaborator
National Cancer Institute (NCI)
Collaborator
Kentucky Small Business Innovation Research / Small Business Technology Transfer (SBIR/STTR)
Collaborator
Source ClinicalTrials.gov