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Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection

Study Purpose

The present study aims to evaluate and compare with the histopathological analysis the various margin-assessment systems, including ultrasound, florescence, brightfield vision, new optical filters and microscope image post-processing systems, for the treatment of High Grade Gliomas (HGGs)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

Patients with radiological, clinical and anamnestic picture compatible with a new diagnosis of Glioblastoma for whom there is an indication for cytoreductive surgery at the Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.

Exclusion Criteria:

- Patients aged less than 18 years at the time of radiological diagnosis.

- Patients who have received radiation therapy in the same area as the neoplasm of interest.

- Patients contraindicated to 5-ALA administration.

- Patients whose neoplasm is in close proximity to functionally eloquent areas (Primary Motor, Broca's, Wernicke's areas) - Patients who have not given their consent to take part in the research

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05330559
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alessandro - Perin, MD - PhD
Principal Investigator Affiliation	Fondazione IRCCS Istituto Neurologico Carlo Besta
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma

Additional Details

Extent of Resection represents the cornerstone of surgery in terms of improving the prognosis of the patient with High Grade Gliomas, but total removal of neoplastic tissue is prevented by the amount of infiltration that is undetectable either by traditional preoperative MRI techniques or by the naked eye during surgery. Several techniques are currently used to define margins in the surgical setting, but the literature available on them to date is mostly focused on the assessment of postoperative GTR (Gross Total Resection), which tends to underestimate neoplastic tissue infiltration. The evaluation of the efficacy of these techniques in detecting tumour infiltration by comparing them with the histopathology response on intraoperative biopsies taken after the debulking phase of the neoplasm could overcome this sensitivity limitation. The study therefore intends to develop an algorithm that allows to discern between tumour infiltration and healthy parenchyma by means of different margin-assessment techniques in order to maximise the extent of resection in patients with HGGs.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Alessandro Perin, MD -PhD

[email protected]

02-23942412

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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