CNSFLUOCERTUMNCT07233954
Intraoperative Use of I.V. Sodium Fluorescein in Suspected CNS Tumors
An observational study of CNS, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
The FLUO.CER.TUM study is a prospective observational clinical trial conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan, Italy. It investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of suspected malignant tumors… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CNS
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2016to 31 Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of both genders, at any age.
Who may be able to join
- Patients of both genders, at any age.
- Patients with suspected aggressive lesion of the CNS, as suggested by pre-operative MRI or CT with i.v. contrast agent administration.
Who cannot join
- Impossibility to give consent due to cognitive deficits or language disorder.
- Known allergy to contrast agents and/or history of previous anaphylactic shocks.
- Known severe previous adverse reactions to Fluorescein
- Acute myocardial infarction or stroke in the last 90 days.
- Severe renal failure;
- Severe hepatic failure;
- Women in their first trimester of pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Morgan A Broggi, MD, + 39 02.2394, morgan.broggi@istituto-besta.it
About this study
Official title: Use of i.v. Sodium Fluorescein as a Fluorescent Intra-operative Tracer in Patients With Suspected Malignant Neoplasms of the CNS
The FLUO.CER.TUM study is a prospective observational clinical trial conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan, Italy. It investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of suspected malignant tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans.
Malignant brain tumors are notoriously difficult to fully resect due to challenges in distinguishing tumor margins from healthy tissue. Sodium fluorescein, a dye that accumulates in areas where the blood-brain barrier is disrupted, offers a promising solution by enhancing tumor visualization during surgery. When used with a dedicated surgical microscope equipped with a fluorescence filter, fluorescein can help surgeons identify and remove more tumor tissue, potentially improving patient outcomes.
Read more
The study aims to evaluate the effectiveness and safety of fluorescein-guided surgery in a real-world clinical setting. Approximately 800 patients of any age and gender, with suspected aggressive CNS lesions, will be enrolled. Each patient will receive 5 mg/kg of sodium fluorescein intravenously at the induction of anesthesia. Surgery will be performed using fluorescence-guided techniques, and patients will undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations will also be conducted to monitor outcomes and any adverse effects.
The primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include measuring the extent of tumor resection, evaluating post-operative neurological function, and documenting any side effects related to fluorescein administration.
The study adheres to ethical standards, including informed consent and approval by an ethics committee, and will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Data will be anonymized and securely stored, with results potentially published following appropriate review and approval.
Read the detailed description
This clinical study investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of aggressive tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans. The study is conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan and follows a prospective observational design.
Malignant CNS tumors are often difficult to completely remove due to the challenge of distinguishing tumor margins from healthy brain tissue. This limitation affects prognosis, especially in high-grade gliomas. Sodium fluorescein, a dye historically used in ophthalmology, accumulates in areas where the blood-brain barrier is disrupted-such as in aggressive brain tumors-making it a potentially ideal agent for enhancing intraoperative visualization. When used with a surgical microscope equipped with a dedicated fluorescence filter, fluorescein allows surgeons to better identify tumor tissue during resection.
The study includes approximately 800 patients of any age and gender, all presenting with suspected aggressive CNS lesions based on contrast-enhanced imaging. Each patient receives 5 mg/kg of sodium fluorescein intravenously at the induction of anesthesia. Surgery is performed using fluorescence-guided techniques, and patients undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations are conducted before and after surgery, with follow-up extending to the third post-operative day.
The primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include evaluating the extent of tumor resection based on early post-operative imaging, monitoring neurological outcomes, and documenting any adverse reactions to fluorescein. Safety parameters such as blood pressure, heart rate, oxygen saturation, temperature, and renal function are monitored according to guidelines from the Italian Medicines Agency (AIFA).
Ethical approval is obtained from the appropriate Ethics Committee, and all patients provide informed consent prior to participation. The study complies with Good Clinical Practice (GCP) and the Declaration of Helsinki. Data are anonymized and stored securely, and results may be published following review and approval by the involved parties.
- Conditions
- CNS
- Keywords
- Neurosurgical Procedures, Malignant Neoplasms, Surgical Margins, Fluorescein
- Medical subject headings
- Neoplasms, Margins of Excision
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Fluorescence Characteristics: Fluorescence Intensity of CNS Tumors
Fluorescence intensity of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope.
Metric: Visual intensity of fluorescence in relation to tumor margins (measured on a standardized scale).
Measured: During surgical procedure
Intraoperative Fluorescence Characteristics: Fluorescence Distribution of CNS Tumors
Fluorescence distribution of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope.
Metric: Spatial distribution of fluorescence relative to tumor margins (e.g., focal vs. diffuse)
Measured: During surgery
Intraoperative Fluorescence Characteristics: Fluorescence Clarity of CNS Tumors
Fluorescence clarity of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope.
Metric: Sharpness/definition of fluorescence edges in relation to tumor margins (scored visually)
Measured: During surgery
Secondary outcomes (3)
Extent of Tumor Resection
Quantitative evaluation of the percentage of tumor removed, based on early post-operative MRI or CT with contrast.
Metric: Volume of residual tumor compared to pre-operative imaging.
Measured: Within 72 hours post-surgery
Post-operative Neurological Function
Description: Assessment of neurological status following surgery, including motor, sensory, and cognitive functions.
Metric: Standard neurological examination scores.
Measured: Within 72 hours post-surgery
Adverse Reactions to Fluorescein
Monitoring and documentation of any side effects or adverse events related to the administration of sodium fluorescein.
Metric: Incidence and severity of adverse events (e.g., allergic reactions, renal/hepatic changes)
Measured: Up to 3 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start13 Jan 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for CNSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan A Broggi, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233954
- Sponsor's protocol ID
- FLUO.CER.TUM
- Acronym
- FLUOCERTUM
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberts DW, Hartov A, Kennedy FE, Miga MI, Paulsen KD. Intraoperative brain shift and deformation: a quantitative analysis of cortical displacement in 28 cases. Neurosurgery. 1998 Oct;43(4):749-58; discussion 758-60. doi: 10.1097/00006123-199810000-00010.
PubMed 9766300Rasmussen IA Jr, Lindseth F, Rygh OM, Berntsen EM, Selbekk T, Xu J, Nagelhus Hernes TA, Harg E, Haberg A, Unsgaard G. Functional neuronavigation combined with intra-operative 3D ultrasound: initial experiences during surgical resections close to eloquent brain areas and future directions in automatic brain shift compensation of preoperative data. Acta Neurochir (Wien). 2007;149(4):365-78. doi: 10.1007/s00701-006-1110-0. Epub 2007 Feb 19.
PubMed 17308976Ramirez C, Bowman C, Maurage CA, Dubois F, Blond S, Porchet N, Escande F. Loss of 1p, 19q, and 10q heterozygosity prospectively predicts prognosis of oligodendroglial tumors--towards individualized tumor treatment? Neuro Oncol. 2010 May;12(5):490-9. doi: 10.1093/neuonc/nop071. Epub 2010 Feb 14.
PubMed 20156805Pedersen MW, Meltorn M, Damstrup L, Poulsen HS. The type III epidermal growth factor receptor mutation. Biological significance and potential target for anti-cancer therapy. Ann Oncol. 2001 Jun;12(6):745-60. doi: 10.1023/a:1011177318162.
PubMed 11484948Ohue S, Kumon Y, Nagato S, Kohno S, Harada H, Nakagawa K, Kikuchi K, Miki H, Ohnishi T. Evaluation of intraoperative brain shift using an ultrasound-linked navigation system for brain tumor surgery. Neurol Med Chir (Tokyo). 2010;50(4):291-300. doi: 10.2176/nmc.50.291.
PubMed 20448420Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8. doi: 10.1111/j.1442-9071.2006.01136.x.
PubMed 16451256Koc K, Anik I, Cabuk B, Ceylan S. Fluorescein sodium-guided surgery in glioblastoma multiforme: a prospective evaluation. Br J Neurosurg. 2008 Feb;22(1):99-103. doi: 10.1080/02688690701765524.
PubMed 18224529Heimberger AB, Crotty LE, Archer GE, Hess KR, Wikstrand CJ, Friedman AH, Friedman HS, Bigner DD, Sampson JH. Epidermal growth factor receptor VIII peptide vaccination is efficacious against established intracerebral tumors. Clin Cancer Res. 2003 Sep 15;9(11):4247-54.
PubMed 14519652Hegi ME, Diserens AC, Godard S, Dietrich PY, Regli L, Ostermann S, Otten P, Van Melle G, de Tribolet N, Stupp R. Clinical trial substantiates the predictive value of O-6-methylguanine-DNA methyltransferase promoter methylation in glioblastoma patients treated with temozolomide. Clin Cancer Res. 2004 Mar 15;10(6):1871-4. doi: 10.1158/1078-0432.ccr-03-0384.
PubMed 15041700Hall WA, Truwit CL. Intraoperative magnetic resonance imaging. Acta Neurochir Suppl. 2011;109:119-29. doi: 10.1007/978-3-211-99651-5_19.
PubMed 20960331Gulati S, Berntsen EM, Solheim O, Kvistad KA, Haberg A, Selbekk T, Torp SH, Unsgaard G. Surgical resection of high-grade gliomas in eloquent regions guided by blood oxygenation level dependent functional magnetic resonance imaging, diffusion tensor tractography, and intraoperative navigated 3D ultrasound. Minim Invasive Neurosurg. 2009 Feb;52(1):17-24. doi: 10.1055/s-0028-1104566. Epub 2009 Feb 26.
PubMed 19247900Esposito V, Paolini S, Morace R, Colonnese C, Venditti E, Calistri V, Cantore G. Intraoperative localization of subcortical brain lesions. Acta Neurochir (Wien). 2008 Jun;150(6):537-42; discussion 543. doi: 10.1007/s00701-008-1592-z. Epub 2008 May 6.
PubMed 18458808Eoli M, Silvani A, Pollo B, Bianchessi D, Menghi F, Valletta L, Broggi G, Boiardi A, Bruzzone MG, Finocchiaro G. Molecular markers of gliomas: a clinical approach. Neurol Res. 2006 Jul;28(5):538-41. doi: 10.1179/016164106X116827.
PubMed 16808886Cairncross JG, Ueki K, Zlatescu MC, Lisle DK, Finkelstein DM, Hammond RR, Silver JS, Stark PC, Macdonald DR, Ino Y, Ramsay DA, Louis DN. Specific genetic predictors of chemotherapeutic response and survival in patients with anaplastic oligodendrogliomas. J Natl Cancer Inst. 1998 Oct 7;90(19):1473-9. doi: 10.1093/jnci/90.19.1473.
PubMed 9776413Albert FK, Forsting M, Sartor K, Adams HP, Kunze S. Early postoperative magnetic resonance imaging after resection of malignant glioma: objective evaluation of residual tumor and its influence on regrowth and prognosis. Neurosurgery. 1994 Jan;34(1):45-60; discussion 60-1. doi: 10.1097/00006123-199401000-00008.
PubMed 8121569
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of i.v. Sodium Fluorescein as a Fluorescent Intra-operative Tracer in Patients With Suspected Malignant Neoplasms of the CNS
- ClinicalTrials.gov ID
- NCT07233954
- Acronym / sponsor ID
- FLUOCERTUM / FLUO.CER.TUM
- Conditions
- CNS
- Keywords
- Neurosurgical Procedures, Malignant Neoplasms, Surgical Margins, Fluorescein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Nov 2025 (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.
The FLUO.CER.TUM study is a prospective observational clinical trial conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan, Italy. It investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of suspected malignant tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans.
Malignant brain tumors are notoriously difficult to fully resect due to challenges in distinguishing tumor margins from healthy tissue. Sodium fluorescein, a dye that accumulates in areas where the blood-brain barrier is disrupted, offers a promising solution by enhancing tumor visualization during surgery. When used with a dedicated surgical microscope equipped with a fluorescence filter, fluorescein can help surgeons identify and remove more tumor tissue, potentially improving patient outcomes.
The study aims to evaluate the effectiveness and safety of fluorescein-guided surgery in a real-world clinical setting. Approximately 800 patients of any age and gender, with suspected aggressive CNS lesions, will be enrolled. Each patient will receive 5 mg/kg of sodium fluorescein intravenously at the induction of anesthesia. Surgery will be performed using fluorescence-guided techniques, and patients will undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations will also be conducted to monitor outcomes and any adverse effects.
The primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include measuring the extent of tumor resection, evaluating post-operative neurological function, and documenting any side effects related to fluorescein administration.
The study adheres to ethical standards, including informed consent and approval by an ethics committee, and will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Data will be anonymized and securely stored, with results potentially published following appropriate review and approval.
Detailed description
This clinical study investigates the intraoperative use of intravenous sodium fluorescein as a fluorescent tracer to assist in the surgical resection of aggressive tumors of the central nervous system (CNS). These tumors typically present as contrast-enhancing masses on pre-operative MRI or CT scans. The study is conducted at the IRCCS Foundation Neurological Institute "Carlo Besta" in Milan and follows a prospective observational design.
Malignant CNS tumors are often difficult to completely remove due to the challenge of distinguishing tumor margins from healthy brain tissue. This limitation affects prognosis, especially in high-grade gliomas. Sodium fluorescein, a dye historically used in ophthalmology, accumulates in areas where the blood-brain barrier is disrupted-such as in aggressive brain tumors-making it a potentially ideal agent for enhancing intraoperative visualization. When used with a surgical microscope equipped with a dedicated fluorescence filter, fluorescein allows surgeons to better identify tumor tissue during resection.
The study includes approximately 800 patients of any age and gender, all presenting with suspected aggressive CNS lesions based on contrast-enhanced imaging. Each patient receives 5 mg/kg of sodium fluorescein intravenously at the induction of anesthesia. Surgery is performed using fluorescence-guided techniques, and patients undergo pre- and post-operative imaging to assess the extent of resection. Clinical and neurological evaluations are conducted before and after surgery, with follow-up extending to the third post-operative day.
The primary objective is to qualitatively assess the intraoperative fluorescence characteristics of CNS tumors. Secondary objectives include evaluating the extent of tumor resection based on early post-operative imaging, monitoring neurological outcomes, and documenting any adverse reactions to fluorescein. Safety parameters such as blood pressure, heart rate, oxygen saturation, temperature, and renal function are monitored according to guidelines from the Italian Medicines Agency (AIFA).
Ethical approval is obtained from the appropriate Ethics Committee, and all patients provide informed consent prior to participation. The study complies with Good Clinical Practice (GCP) and the Declaration of Helsinki. Data are anonymized and stored securely, and results may be published following review and approval by the involved parties.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both genders, at any age.
Key inclusion criteria (2 listed)
- Patients of both genders, at any age.
- Patients with suspected aggressive lesion of the CNS, as suggested by pre-operative MRI or CT with i.v. contrast agent administration.
Key exclusion criteria (7 listed)
- Impossibility to give consent due to cognitive deficits or language disorder.
- Known allergy to contrast agents and/or history of previous anaphylactic shocks.
- Known severe previous adverse reactions to Fluorescein
- Acute myocardial infarction or stroke in the last 90 days.
- Severe renal failure;
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
Intraoperative Fluorescence Characteristics: Fluorescence Intensity of CNS Tumors
Time frame: During surgical procedure
Fluorescence intensity of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope. Metric: Visual intensity of fluorescence in relation to tumor margins (measured on a standardized scale).
Intraoperative Fluorescence Characteristics: Fluorescence Distribution of CNS Tumors
Time frame: During surgery
Fluorescence distribution of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope. Metric: Spatial distribution of fluorescence relative to tumor margins (e.g., focal vs. diffuse)
Intraoperative Fluorescence Characteristics: Fluorescence Clarity of CNS Tumors
Time frame: During surgery
Fluorescence clarity of aggressive CNS tumors during surgery using sodium fluorescein and a dedicated surgical microscope. Metric: Sharpness/definition of fluorescence edges in relation to tumor margins (scored visually)
3 secondary outcomes
Extent of Tumor Resection
Time frame: Within 72 hours post-surgery
Post-operative Neurological Function
Time frame: Within 72 hours post-surgery
Adverse Reactions to Fluorescein
Time frame: Up to 3 days post-surgery
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 11 Feb 2026.
- Background: PubMed 9766300Roberts DW, Hartov A, Kennedy FE, Miga MI, Paulsen KD. Intraoperative brain shift and deformation: a quantitative analysis of cortical displacement in 28 cases. Neurosurgery. 1998 Oct;43(4):749-58; discussion 758-60. doi: 10.1097/00006123-199810000-00010.
- Background: PubMed 17308976Rasmussen IA Jr, Lindseth F, Rygh OM, Berntsen EM, Selbekk T, Xu J, Nagelhus Hernes TA, Harg E, Haberg A, Unsgaard G. Functional neuronavigation combined with intra-operative 3D ultrasound: initial experiences during surgical resections close to eloquent brain areas and future directions in automatic brain shift compensation of preoperative data. Acta Neurochir (Wien). 2007;149(4):365-78. doi: 10.1007/s00701-006-1110-0. Epub 2007 Feb 19.
- Background: PubMed 20156805Ramirez C, Bowman C, Maurage CA, Dubois F, Blond S, Porchet N, Escande F. Loss of 1p, 19q, and 10q heterozygosity prospectively predicts prognosis of oligodendroglial tumors--towards individualized tumor treatment? Neuro Oncol. 2010 May;12(5):490-9. doi: 10.1093/neuonc/nop071. Epub 2010 Feb 14.
- Background: PubMed 11484948Pedersen MW, Meltorn M, Damstrup L, Poulsen HS. The type III epidermal growth factor receptor mutation. Biological significance and potential target for anti-cancer therapy. Ann Oncol. 2001 Jun;12(6):745-60. doi: 10.1023/a:1011177318162.
- Background: PubMed 20448420Ohue S, Kumon Y, Nagato S, Kohno S, Harada H, Nakagawa K, Kikuchi K, Miki H, Ohnishi T. Evaluation of intraoperative brain shift using an ultrasound-linked navigation system for brain tumor surgery. Neurol Med Chir (Tokyo). 2010;50(4):291-300. doi: 10.2176/nmc.50.291.
- Background: PubMed 16451256Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8. doi: 10.1111/j.1442-9071.2006.01136.x.
- Background: PubMed 18224529Koc K, Anik I, Cabuk B, Ceylan S. Fluorescein sodium-guided surgery in glioblastoma multiforme: a prospective evaluation. Br J Neurosurg. 2008 Feb;22(1):99-103. doi: 10.1080/02688690701765524.
- Background: PubMed 14519652Heimberger AB, Crotty LE, Archer GE, Hess KR, Wikstrand CJ, Friedman AH, Friedman HS, Bigner DD, Sampson JH. Epidermal growth factor receptor VIII peptide vaccination is efficacious against established intracerebral tumors. Clin Cancer Res. 2003 Sep 15;9(11):4247-54.
- Background: PubMed 15041700Hegi ME, Diserens AC, Godard S, Dietrich PY, Regli L, Ostermann S, Otten P, Van Melle G, de Tribolet N, Stupp R. Clinical trial substantiates the predictive value of O-6-methylguanine-DNA methyltransferase promoter methylation in glioblastoma patients treated with temozolomide. Clin Cancer Res. 2004 Mar 15;10(6):1871-4. doi: 10.1158/1078-0432.ccr-03-0384.
- Background: PubMed 20960331Hall WA, Truwit CL. Intraoperative magnetic resonance imaging. Acta Neurochir Suppl. 2011;109:119-29. doi: 10.1007/978-3-211-99651-5_19.
- Background: PubMed 19247900Gulati S, Berntsen EM, Solheim O, Kvistad KA, Haberg A, Selbekk T, Torp SH, Unsgaard G. Surgical resection of high-grade gliomas in eloquent regions guided by blood oxygenation level dependent functional magnetic resonance imaging, diffusion tensor tractography, and intraoperative navigated 3D ultrasound. Minim Invasive Neurosurg. 2009 Feb;52(1):17-24. doi: 10.1055/s-0028-1104566. Epub 2009 Feb 26.
- Background: PubMed 18458808Esposito V, Paolini S, Morace R, Colonnese C, Venditti E, Calistri V, Cantore G. Intraoperative localization of subcortical brain lesions. Acta Neurochir (Wien). 2008 Jun;150(6):537-42; discussion 543. doi: 10.1007/s00701-008-1592-z. Epub 2008 May 6.
- Individual participant dataSharing planned: No
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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.
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Morgan A Broggi, MD principal investigator
Fondazione IRCCS Istituto Neurologico Carlo Besta
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 CNS, 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Fluorescence Characteristics: Fluorescence Intensity of CNS Tumors (time frame: During surgical procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233954, which also lists 15 linked publications.
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 11 Feb 2026.