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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Fady T Charbel, MD — University of Illinois Chicago
• Study coordinator: Fady T Charbel, MD
• Email: fcharbel@uic.edu
• Phone: 312-996-4842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.