Clinical trial · Observational
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors and/or Solid Tumors Including | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma - Category | — | UNRESOLVED | — |
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Glioblastoma Patients
- description
- Patients aged 18 or older with a first diagnosis of supratentorial glioblastoma (WHO Grade 4), confirmed by histology, who are candidates for 5-ALA fluorescence-guided surgery.
- label
- Other Brain Tumor Patients
- description
- Patients aged 18 or older with other brain tumors (in differential diagnosis with glioblastoma) who are candidates for 5-ALA fluorescence-guided surgery.
Primary outcomes (1)
- measure
- Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
- timeFrame
- 2 years
- description
- PpIX fluorescence level in blood (serum and plasma) and urine at different time-points (pre-administration, 12h post-administration, and potentially other timepoints depending on preliminary observations) in patients with glioblastoma.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available