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 range18 Years
SexALL
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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.
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