Actively Recruiting
Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
Led by University of Illinois at Chicago · Updated on 2025-11-12
8
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
M
Marginum Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. The current golden standard for intraoperative glioma detection is fluorescence-guided surgery (FGS) using 5-ALA. In 5-ALA FGS the drug-induced fluorescence helps to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are routinely used to remove cancerous tissues, but so far, the analysis of the suction waste has not been used in near real-time tissue detection.
CONDITIONS
Official Title
Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient admitted to neurosurgery department for surgical resection of a suspected grade 3 or 4 glioma with 5-ALA (cases)
- Patient admitted to neurosurgery department for surgical resection of a primary or secondary brain tumor with no 5-ALA (controls)
- Patients aged 18 years old or older
- Informed consent obtained
You will not qualify if you...
- Patients who are children, pregnant, prisoners, or intellectually disabled
- Participants are not randomized due to limited eligible patients and long recruitment period
- Patients must be screened, informed, and enrolled only after eligibility verification and written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
Actively Recruiting
Research Team
F
Fady T Charbel, MD
CONTACT
L
Linda Rose-Finnell, MPA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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