Brain Tumors and/or Solid Tumors IncludingFLUO-LBNCT07420543
Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
An observational study of Brain Tumors and/or Solid Tumors Including and Glioblastoma, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors and/or Solid Tumors Including, Glioblastoma, Glioblastoma (GBM)
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 Patients with brain tumors whose treatment course involves fluorescence-guided surgery 5-ALA.
Who may be able to join
- 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.
- Patient aged 18 years or older
- Ability of the patient to give informed consent.
- Suitability for surgery with fluorescence guidance using 5-ALA.
Who cannot join
- 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.
- Patients suffering from systemic tumors (besides the primary of the brain metastasis).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a prospective observational study. Patients with suspected brain tumors requiring 5-ALA fluorescence-guided surgery will be enrolled. Samples of plasma, serum, and urine will be collected at a minimum of two timepoints: once before 5-ALA administration (baseline, T1) and again 12 hours after administration (T2), when PpIX levels are expected to be highest. All sample collection and processing will occur in low-light conditions to prevent PpIX degradation. Samples will be stored at -80°C. Fluorometric analysis (Perkin Elmer Wallac 1420 Victor2 Microplate Reader) will be performed to measure PpIX fluorescence. Additionally, each patient will undergo a pre-operative MRI as per routine care to measure tumor volume, which will be correlated with fluorescence data.
- Conditions
- Brain Tumors and/or Solid Tumors Including, Glioblastoma, Glioblastoma (GBM), Glioblastoma - Category
- Keywords
- Glioblastoma (GBM), Glioblastoma, Liquid Biopsy, GBM, 5-ALA, Protoporphyrin IX (PpIX), Fluorescence
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma Patients | Patients aged 18 or older with a first diagnosis of supratentorial glioblastoma (WHO Grade 4), confirmed by histology, who are candidates for 5-ALA fluorescence-guided surgery. | |
| Other Brain Tumor Patients | Patients aged 18 or older with other brain tumors (in differential diagnosis with glioblastoma) who are candidates for 5-ALA fluorescence-guided surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
PpIX fluorescence level in blood (serum and plasma) and urine at different time-points (pre-administration, 12h post-administration, and potentially other timepoints depending on preliminary observations) in patients with glioblastoma.
Measured: 2 years
Secondary outcomes (5)
PpIX Fluorescence Level in Control/Other Brain Tumor Patients
PpIX fluorescence level in blood (serum and plasma) and urine at different time-points in controls/patients with other brain tumor pathologies.
Measured: 2 years
Correlation of Fluorescence with Histopathological Characteristics
Correlation of PpIX fluorescence levels with histopathological characteristics of the tumor tissue.
Measured: 2 years
Correlation of Fluorescence with Tumor Tissue Fluorescence
Correlation of PpIX fluorescence levels in liquid biopsy (blood/urine) with the observed fluorescence of the tumor tissue during surgery
Measured: 2 years
Correlation of Fluorescence with MRI Lesion Volumes
Correlation of PpIX fluorescence levels with lesion volumes measured on pre-operative Magnetic Resonance Imaging (MRI).
Measured: 2 years
Kinetics of 5-ALA-induced Fluorescence
Describe the kinetics (changes over time) of 5-ALA-induced fluorescence in plasma and urine levels.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start27 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumors and/or Solid Tumors IncludingStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420543
- Sponsor's protocol ID
- FLUO-LB
- Acronym
- FLUO-LB
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Sponsor (Fondazione IRCCS Istituto Neurologico Carlo Besta) is the owner of the data resulting from the study. All Investigators participating in the study should be made aware of such circumstance and not to disseminate information or data without the prior written consent by the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
- ClinicalTrials.gov ID
- NCT07420543
- Acronym / sponsor ID
- FLUO-LB / FLUO-LB
- Conditions
- Brain Tumors and/or Solid Tumors Including, Glioblastoma, Glioblastoma (GBM), Glioblastoma - Category
- Keywords
- Glioblastoma (GBM), Glioblastoma, Liquid Biopsy, GBM, 5-ALA, Protoporphyrin IX (PpIX), Fluorescence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- University of Milan, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Study start
- 27 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective observational study. Patients with suspected brain tumors requiring 5-ALA fluorescence-guided surgery will be enrolled. Samples of plasma, serum, and urine will be collected at a minimum of two timepoints: once before 5-ALA administration (baseline, T1) and again 12 hours after administration (T2), when PpIX levels are expected to be highest. All sample collection and processing will occur in low-light conditions to prevent PpIX degradation. Samples will be stored at -80°C. Fluorometric analysis (Perkin Elmer Wallac 1420 Victor2 Microplate Reader) will be performed to measure PpIX fluorescence. Additionally, each patient will undergo a pre-operative MRI as per routine care to measure tumor volume, which will be correlated with fluorescence data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma Patients | – | –Patients aged 18 or older with a first diagnosis of supratentorial glioblastoma (WHO Grade 4), confirmed by histology, who are candidates for 5-ALA fluorescence-guided surgery. |
| Other Brain Tumor Patients | – | –Patients aged 18 or older with other brain tumors (in differential diagnosis with glioblastoma) who are candidates for 5-ALA fluorescence-guided surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 Patients with brain tumors whose treatment course involves fluorescence-guided surgery 5-ALA.
Key inclusion criteria (7 listed)
- 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.
- Patient aged 18 years or older
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
Time frame: 2 years
PpIX fluorescence level in blood (serum and plasma) and urine at different time-points (pre-administration, 12h post-administration, and potentially other timepoints depending on preliminary observations) in patients with glioblastoma.
5 secondary outcomes
PpIX Fluorescence Level in Control/Other Brain Tumor Patients
Time frame: 2 years
Correlation of Fluorescence with Histopathological Characteristics
Time frame: 2 years
Correlation of Fluorescence with Tumor Tissue Fluorescence
Time frame: 2 years
Correlation of Fluorescence with MRI Lesion Volumes
Time frame: 2 years
Kinetics of 5-ALA-induced Fluorescence
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. The Sponsor (Fondazione IRCCS Istituto Neurologico Carlo Besta) is the owner of the data resulting from the study. All Investigators participating in the study should be made aware of such circumstance and not to disseminate information or data without the prior written consent by the Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors and/or Solid Tumors Including and Glioblastoma, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.