NCT07420543 Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
| NCT ID | NCT07420543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Brain Tumors and/or Solid Tumors Including |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-01-18 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2017-01-18 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07420543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumors and/or Solid Tumors Including. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07420543 currently recruiting?
Yes, NCT07420543 is actively recruiting participants. Contact the research team at francesco.dimeco@istituto-besta.it for enrollment information.
Where is the NCT07420543 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07420543 clinical trial?
NCT07420543 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 30 participants.