Recruiting

5-ALA

Sponsor:

University of Illinois at Chicago

Code:

NCT07111182

Conditions

Brain Neoplasms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

HIVEN Medical Device

Study Details

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.

Conditions

Brain Neoplasms

Study ID

NCT07111182

Start date

Oct 27, 2025

Status verified date

Nov, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

HIVEN 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Fady T Charbel, MD

312-996-4842fcharbel@uic.edu

Linda Rose-Finnell, MPA

312-996-4842lfinnell@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60608

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.