Brain NeoplasmsATM5-ALANCT07111182
Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
A study testing HIVEN Medical Device in people with Brain Neoplasms, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- HIVEN Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
Official title: ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
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.
Read the 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.
- Conditions
- Brain Neoplasms
- Being tested
- HIVEN Medical Device
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVEN Medical DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Usability Assessment | Other | 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. Receives: Device: HIVEN Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the increased detection of fluorescence during surgery (performance)
Fluorescence detection rate during surgery measured per seconds of video (performance)
Measured: During procedure video recording
Assess the safety and benefit-risk profile versus a legally marketed alternative therapy i.e. visual fluorescence guidance (safety)
Benefit-risk profile based on user's systematic questionnaires indicates non-inferiority to visual fluorescence guidance (safety)
Measured: During procedure user's questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start27 Oct 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Marginum Ltd.
- Responsible party
- Sponsor
- Investigators
- Fady T Charbel, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111182
- Sponsor's protocol ID
- 2025-0505
- Acronym
- ATM5-ALA
- Status last verified
- Nov 2025
- First submitted
- 31 Jul 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT07111182
- Acronym / sponsor ID
- ATM5-ALA / 2025-0505
- Conditions
- Brain Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Marginum Ltd.
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Usability Assessment | Other | Device: HIVEN Medical DeviceNeurosurgeons 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVEN Medical DeviceA 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. | Device | Usability Assessment |
Primary outcome
Demonstrate the increased detection of fluorescence during surgery (performance)
Time frame: 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)
Time frame: During procedure user's questionnaires
Benefit-risk profile based on user's systematic questionnaires indicates non-inferiority to visual fluorescence guidance (safety)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fady T Charbel, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIVEN Medical Device in people with Brain Neoplasms, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fady T Charbel, MD (312-996-4842, fcharbel@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the increased detection of fluorescence during surgery (performance) (time frame: During procedure video recording). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.