Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
30 participants
OBSERVATIONAL
2017-11-17
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
NCT00001148
Investigational Imaging Technique During Brain Surgery
NCT05513859
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
NCT05692635
Enhanced Detection in Glioma Excision
NCT04556929
MRI Predictors of Response to Tumor Treating Fields
NCT03642080
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
At the induction of anesthesia, patients will receive 5 mg/kg of intravenous sodium 5-aminolevulinic acid (5-ALA) or fluorescein. Surgery will be performed under the guidance of the operative fluorescence microscope (PENTERO with fluorescence kit + YELLOW 560, Carl Zeiss) or (PENTERO 900 + BLUE 400, Carl Zeiss). The operating room light will be dimmed for optimum reproduction of the fluorescent light. Tumor removal will be continued until no fluorescent area is visualized. To evaluate the accuracy of the device in the identification of tumor tissue, six samples will be biopsied from the tumor resection margin for each patient; three in the fluorescent area and three in the non-fluorescent area for the assessment of positive and negative predictive values of the devices, respectively. These biopsied tissues will be taken to the clinical pathology laboratory for the standard histological analysis.
To compare the accuracy of the two imaging systems in identifying tumor tissues, the tumor resection area will be visually observed by the surgeon and video recorded using the new loupe-based device at two time points (at least): immediately before and immediately after tumor removal. Additional fluorescence images may be taken during surgery as long as the surgical workflow is not impacted. Moreover, the four fresh biopsies (2 in the fluorescent area and 2 in the non-fluorescent area) taken from the tumor margin based on the operative microscope diagnosis will also be examined intraoperatively by the loupe-based device to determine whether they are fluorescent or non-fluorescent.
To discriminate between clear tumor tissue and the peritumoral areas, the postoperative histological analysis of the biopsied samples taken from the tumor margins will be classified on the basis of the current 2016 WHO classification. The neuropathologist will be blinded to the fluorescence characteristics of the biopsied samples.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* at least 18 years of age
* able to understand the consent
Exclusion Criteria
* under 18 years of age
* patients undergoing emergency surgery
* inability to give consent due to dysphagia or language barrier
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioptics Technology LLC
UNKNOWN
National Cancer Institute (NCI)
NIH
Kentucky Small Business Innovation Research / Small Business Technology Transfer (SBIR/STTR)
UNKNOWN
Guoqiang Yu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guoqiang Yu
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guoqiang Yu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kentucky
Lexington, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCC-17-0605-F1V
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.