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Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach

RECRUITINGSponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Actively Recruiting
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Started2017-01-18
Est. completion2026-05
Eligibility
Age18 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions5

Brain Tumors and/or Solid Tumors IncludingCancerGlioblastomaGlioblastoma (GBM)Glioblastoma - Category

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