Recruiting

Fluorescence Imaging

Sponsor:

Guoqiang Yu

Code:

NCT04780009

Conditions

Glioblastoma Multiforme

Anaplastic Astrocytoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04780009

Start date

Nov 17, 2017

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Positive Predictive Value (PPV) [ Time Frame: 1 day ]
  • Negative Predictive Value (NPV) [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Principal Investigator:

Thomas Pittman, MD

More Information

Sponsor

Guoqiang Yu

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • fluorescence
  • resection
  • 5-ALA
  • fluorescein
  • optical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Guoqiang Yu on 2026-06-03.