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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07111182
Status
Recruiting
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Conditions

  • Brain Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • HIVEN Medical Device — DEVICE
    A medical device (HIVEN®) detects 5-ALA-induced fluorescence from the surgical suction and gives sound feedback to the operating surgeon indicating tumor tissue and overcoming the challenges is the contemporary FGS methods. The device is used for detecting fluorescence of flowing tissues within a transparent tube and providing auditory feedback of tissue fluorescence for neurosurgeons. There is no patient contact intended with this device.

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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.

Primary Outcome Measure

Demonstrate the increased detection of fluorescence during surgery (performance) [ Time Frame: During procedure video recording ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60608-

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