Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery

NCT07111182 | Recruiting DMC FDA Device

• 1 other identifier: 2025-0505
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Demonstrate the increased detection of fluorescence during surgery (performance)

  Fluorescence detection rate during surgery measured per seconds of video (performance)

  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)

  During procedure user's questionnaires

Study Arms (1)

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.

Device: HIVEN Medical Device

Interventions

HIVEN Medical Device 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.

Usability Assessment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Marginum Ltd.: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fady T Charbel, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fady T Charbel, MD

CONTACT

312-996-4842; fcharbel@uic.edu

Linda Rose-Finnell, MPA

CONTACT

312-996-4842; lfinnell@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 8, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)