Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach (NCT07420543) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
Italy30 participantsStarted 2017-01-18
Plain-language summary
Glioblastoma (GBM) is the most common and lethal primary brain tumor. Identifying blood biomarkers that reflect the tumor's status is a major unmet need for optimal clinical management. 5-ALA (5-Aminolevulinic Acid) administration leads to the accumulation of fluorescent Protoporphyrin IX (PpIX) in GBM cells, allowing identification during surgery. This project aims to leverage 5-ALA induced fluorescence to maximize the informational power of plasma liquid biopsy as a tool for diagnosis, post-treatment follow-up, and as a prognostic tool in patients with GBM.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion Criteria (Glioblastoma Patients):
* Patient aged 18 years or older
* Diagnosis of supratentorial glioblastoma at its first occurrence (Grade 4, WHO 2021), confirmed through histological analysis, in a brain area that is accessible for surgical removal.
* Ability of the patient to give informed consent.
* Suitability for surgery with fluorescence guidance using 5-ALA.
Inclusion Criteria (Other Brain Tumors):
* Patient aged 18 years or older
* Ability of the patient to give informed consent.
* Suitability for surgery with fluorescence guidance using 5-ALA.
Exclusion Criteria:
Exclusion Criteria (Glioblastoma Patients):
* Presence of other systemic tumors.
* Known allergic sensitivity or contraindications to gadolinium.
* Contraindications to MRI, such as the presence of non-compatible implanted devices.
* Significantly compromised renal function (eGFR \<30 ml/min/1.73 m²), and/or patients undergoing dialysis.
* Conditions that contraindicate surgery with fluorescence guidance using 5-ALA.
Exclusion Criteria (Other Brain Tumors):
* Patients suffering from systemic tumors (besides the primary of the brain metastasis).
* Individuals with known allergies or adverse reactions to gadolinium.
* Individuals with contraindications for MRI, including those with implants not compatible with the procedure.
* Individuals with significantly reduced kidney function (eGFR \< 30 ml/min/1.73 m²), or those undergoing dialysis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
Timeframe: 2 years
Trial details
NCT IDNCT07420543
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta