RecruitingNot ApplicableNCT07111182

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

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


Sponsor

University of Illinois at Chicago

Enrollment

8 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new method to monitor brain tumor tissue during surgery using 5-ALA — a substance that makes certain tumor cells glow under special light — combined with real-time fluid analysis. The goal is to see whether this technique helps surgeons more precisely identify and remove brain tumor tissue. **You may be eligible if...** - You are 18 years or older - You are scheduled for surgery to remove a suspected high-grade brain tumor (grade 3 or 4 glioma) using 5-ALA, OR you are having brain tumor surgery without 5-ALA (control group) - You are able to provide written informed consent before the surgery **You may NOT be eligible if...** - You are under 18 - You are pregnant - You have an intellectual disability - You are in a vulnerable group (prisoners, etc.) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHIVEN 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.


Locations(1)

University of Illinois at Chicago

Chicago, Illinois, United States

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NCT07111182


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