ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Demonstrate the increased detection of fluorescence during surgery (performance)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: HIVEN Medical Device (Device)
结局指标
主要结局
Demonstrate the increased detection of fluorescence during surgery (performance)
时间窗: 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)
时间窗: During procedure user's questionnaires
Benefit-risk profile based on user's systematic questionnaires indicates non-inferiority to visual fluorescence guidance (safety)
次要结局
未报告次要终点