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

NCT07111182 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-11-12

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Marginum Ltd.

    collaborator INDUSTRY

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Fady T Charbel, MD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2027-11-30
Completion
2027-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111182 on ClinicalTrials.gov