NCT07111182 Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
| NCT ID | NCT07111182 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Brain Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 8 participants in total. It began in 2025-10-27 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Fady T Charbel, MD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT07111182 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Brain Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111182 currently recruiting?
Yes, NCT07111182 is actively recruiting participants. Contact the research team at fcharbel@uic.edu for enrollment information.
Where is the NCT07111182 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07111182 clinical trial?
NCT07111182 is sponsored by University of Illinois at Chicago. The principal investigator is Fady T Charbel, MD at University of Illinois at Chicago. The trial plans to enroll 8 participants.