5-ALA guided liquid biopsy to detect glioblastoma signals in blood and urine
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
This project will see if giving 5-ALA during surgery helps reveal tumor-related signals in blood, plasma, and urine of adults having surgery for suspected glioblastoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07420543 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational project enrolling adults who will undergo 5‑ALA fluorescence-guided brain tumor surgery. Blood (plasma and serum) and urine samples are taken before 5‑ALA and about 12 hours after dosing, handled in low light and stored at −80°C to preserve fluorescence. Samples are analyzed for PpIX fluorescence with a microplate reader and correlated with routine preoperative MRI tumor volume. The goal is to determine whether 5‑ALA–enhanced fluorescence can boost the diagnostic and prognostic signal detectable by liquid biopsy.
Who should consider this trial
Good fit: Adults (18+) who can give informed consent and are scheduled for 5‑ALA fluorescence-guided neurosurgery for suspected supratentorial glioblastoma or other brain tumors are ideal candidates.
Not a fit: Patients who cannot receive 5‑ALA or MRI, who have severe renal impairment, other systemic malignancies, or who are not having fluorescence-guided surgery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could lead to a minimally invasive blood or urine test that more accurately reflects tumor burden and helps guide diagnosis and follow-up after surgery.
How similar studies have performed: Liquid biopsy for glioblastoma has shown limited but growing promise, and using intraoperative 5‑ALA to amplify tumor-derived signals is a relatively novel approach with only preliminary data to date.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Di Meco, MD
- Email: francesco.dimeco@istituto-besta.it
- Phone: + 39 02.2394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.