NCT07420543Active, not recruiting
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 27 May 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Diseases
- Glioblastoma
- NCT number
- NCT07420543
What you commit to
- Study type: Observational
- Planned participants: 30
- From 27 May 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals with contraindications for MRI, including those with implants not compatible with the procedure.
Other illness
- Known allergic sensitivity or contraindications to gadolinium.
- Conditions that contraindicate surgery with fluorescence guidance using 5-ALA.
- Individuals with known allergies or adverse reactions to gadolinium.
Lab values
- Significantly compromised renal function (eGFR \<30 ml/min/1.73 m²), and/or patients undergoing dialysis.
- Individuals with significantly reduced kidney function (eGFR \< 30 ml/min/1.73 m²), or those undergoing dialysis.
Other
- Presence of other systemic tumors.
- Contraindications to MRI, such as the presence of non-compatible implanted devices.
- Patients suffering from systemic tumors (besides the primary of the brain metastasis).
Who the study is looking for
- 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.
- Patient aged 18 years or older
- Ability of the patient to give informed consent.
- Suitability for surgery with fluorescence guidance using 5-ALA.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.