Brain Neoplasms
Conditions
Brief 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.
Detailed description
A novel 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 5-ALA (Gleolan, NX Development Corp) has been already FDA-approved since 2017 for fluorescence-guided resection of suspected WHO grade 3 or 4 gliomas. The HIVEN® device has been investigated in Europe during 33 surgeries and the MDR (EU) 2017/745 approval was granted on 09/2025.The device is commercially available in the EU starting from 09/2025. The CE mark is approved for a Class IIb device risk classification. The current medical device study aims to demonstrate the feasibility and the benefit-risk ratio of HIVEN® for detecting tumor fluorescence from the surgical suction waste as a part of the FDA medical device process. The feedback from the device is expected to provide supplementary information on fluorescence and add value to fluorescence-guided surgical workflow.
Interventions
DEVICEHIVEN Medical 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.
Sponsors
Marginum Ltd.
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
In general, the current literature favors more and more aggressive treatments for high-grade III-IV (Barak et al. 2021), grade II (Rossi et al. 2020), and both non-symptomatic and symptomatic low-grade gliomas with progressive features (Zeng et al. 2021).
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
- * 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)
Exclusion criteria
* Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled. * The participants are not randomized. Randomization is not conducted as the number of eligible patients is limited, subjecting to a long recruitment period that reciprocally increases the bias from uncontrollable (evolving) surgical techniques and adjunct treatments. * The patients are screened and informed of the study before the surgical operation and enrolled after verification of eligibility and written informed consent has been received. Potential study participants are identified from the clinic's planned or urgent surgeries list. The participants are contacted before the operation by the research staff and/or the physician responsible for the treatment. The participants are provided with written and oral information about the research and the time to consider their participation. Finally, the participants are asked for their informed consent and enrolled to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the increased detection of fluorescence during surgery (performance) | During procedure video recording | Fluorescence detection rate during surgery measured per seconds of video (performance) |
| Assess the safety and benefit-risk profile versus a legally marketed alternative therapy i.e. visual fluorescence guidance (safety) | During procedure user's questionnaires | Benefit-risk profile based on user's systematic questionnaires indicates non-inferiority to visual fluorescence guidance (safety) |
Countries
United States
Contacts
Primary ContactFady T Charbel, MD
Backup ContactLinda Rose-Finnell, MPA
Outcome results
None listed