Loupe-Based Intraoperative Fluorescence Imaging

NCT04780009 | Recruiting

• 2 other identifiers: MCC-17-0605-F1VR41CA243600-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme; Anaplastic Astrocytoma

Keywords

fluorescence; resection; 5-ALA; fluorescein; optical

Outcome Measures

Primary Outcomes (2)

• Positive Predictive Value (PPV)

  The proportion of samples that are histologically confirmed as tumor-positive among all fluorescent samples will be calculated.

  1 day

• Negative Predictive Value (NPV)

  The proportion of samples that are histologically confirmed as tumor-negative among all fluorescent samples will be calculated.

  1 day

Secondary Outcomes (1)

• Residual Tumor

  1 day

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing glioblastoma multiforme and anaplastic astrocytoma resection recruited from the University of Kentucky Multidisciplinary Oncology Clinic (UK-MOC).

You may qualify if:

• adults with brain malignant gliomas undergoing resection
• at least 18 years of age
• able to understand the consent

You may not qualify if:

• pregnant women
• under 18 years of age
• patients undergoing emergency surgery
• inability to give consent due to dysphagia or language barrier

Sponsors & Collaborators

• Guoqiang Yu: lead
• Bioptics Technology LLC: collaborator
• National Cancer Institute (NCI): collaborator
• Kentucky Small Business Innovation Research / Small Business Technology Transfer (SBIR/STTR): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies in and adjacent to the tumor will be collected for histopathology.

MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Guoqiang Yu, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: November 17, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)