ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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 of secondary brain tumor with no 5-ALA (controls)

• Patients aged 18 years old or older (all patients)

• Informed consent obtained (all patients)

Locations
United States
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Contact Information
Primary
Fady T Charbel, MD
fcharbel@uic.edu
312-996-4842
Backup
Linda Rose-Finnell, MPA
lfinnell@uic.edu
312-996-4842
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 8
Treatments
Other: Usability Assessment
Neurosurgeons and surgical nurses have assessed the usability, performance and safety of the device based on operation video recordings or user testing with high-grade glioma-simulating synthetic phantoms.~neurosurgeons will use the HIVEN® during high-grade glioma surgeries in patients in authentic conditions according to the intended use and IFU and assessed its performance and benefit-risk profile. Surgical nurses gave feedback on the device's preoperative preparations and usability during the interventional study.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago
Collaborators: Marginum Ltd.

This content was sourced from clinicaltrials.gov