No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Other
Who this trial is looking for
This trial is looking for patients with glioblastoma or other brain tumors who can participate in a surgery using a special dye called 5-ALA. Participating may help improve how doctors manage brain tumors by using information from both blood tests and surgical guidance.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have been diagnosed with glioblastoma or another brain tumor
I can give informed consent
I am suitable for surgery with 5-ALA guidance
You may not be able to join if
I have other systemic tumors
I am allergic to gadolinium
I have devices that are not compatible with MRI
I have significantly compromised kidney function
I am undergoing dialysis
I have conditions that prevent surgery with 5-ALA guidance
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 fluor…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 t…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.