Fluorescence-guided suction monitoring to detect tumor tissue during brain surgery

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

This trial will test a device that detects 5-ALA fluorescence in surgical suction to help surgeons find tumor tissue during adult glioma surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07111182 on ClinicalTrials.gov

What this trial studies

The study uses the HIVEN® device to detect 5-ALA–induced fluorescence from surgical suction waste and give audible feedback to the operating surgeon. Participants include adults undergoing resection of suspected WHO grade 3 or 4 gliomas who receive 5-ALA and a control group of adults undergoing resection of primary or secondary brain tumors without 5-ALA. The device has been used in 33 European surgeries and carries a CE mark, and this study aims to demonstrate feasibility and the benefit-risk profile as part of the FDA device process. The HIVEN® signal is intended to supplement conventional visual fluorescence-guided surgery and potentially highlight tumor tissue missed by direct visualization.

Who should consider this trial

Good fit: Adults aged 18 or older who are scheduled for surgical resection of a suspected grade 3 or 4 glioma (with 5-ALA) or adults undergoing resection of a primary or secondary brain tumor (controls) who can give informed consent are eligible.

Not a fit: Children, pregnant people, prisoners, intellectually disabled individuals, and patients whose procedures do not use suction or whose tumors do not produce detectable fluorescence are unlikely to benefit from the device.

Why it matters

Potential benefit: If successful, the device could help surgeons detect tumor tissue that is missed by visual inspection, improving completeness of resection and potentially reducing local recurrence.

How similar studies have performed: 5-ALA fluorescence-guided resection is an established method to improve tumor visualization, and the HIVEN® device is novel but has been used in 33 European surgeries and received CE marking, though US data are limited.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Fady T Charbel, MD — University of Illinois at Chicago
• Study coordinator: Fady T Charbel, MD

Conditions: Brain Neoplasms