Clinical trial · Interventional
Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIVEN Medical Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Usability Assessment
- description
- 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.
- interventionNames
- Device: HIVEN Medical Device
Primary outcomes (2)
- measure
- Demonstrate the increased detection of fluorescence during surgery (performance)
- timeFrame
- During procedure video recording
- description
- Fluorescence detection rate during surgery measured per seconds of video (performance)
- measure
- Assess the safety and benefit-risk profile versus a legally marketed alternative therapy i.e. visual fluorescence guidance (safety)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
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