Clinical trial NCT05330559: Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection
Official title: Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by HGGs

Brief summary: 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)

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Primary Outcome
timeFrame: year 2
Secondary outcomes:
measure: Secondary Outcome
timeFrame: year 2
Other outcomes:
measure: third Outcome
timeFrame: year 2
measure: fourth Outcome
timeFrame: year 2
Locations:
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Alessandro - Perin, MD - PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Stepp H, Stummer W. 5-ALA in the management of malignant glioma. Lasers Surg Med. 2018 Jul;50(5):399-419. doi: 10.1002/lsm.22933. Epub 2018 May 8.
citation: Kiesel B, Mischkulnig M, Woehrer A, Martinez-Moreno M, Millesi M, Mallouhi A, Czech T, Preusser M, Hainfellner JA, Wolfsberger S, Knosp E, Widhalm G. Systematic histopathological analysis of different 5-aminolevulinic acid-induced fluorescence levels in newly diagnosed glioblastomas. J Neurosurg. 2018 Aug;129(2):341-353. doi: 10.3171/2017.4.JNS162991. Epub 2017 Oct 27.
citation: Del Bene M, Perin A, Casali C, Legnani F, Saladino A, Mattei L, Vetrano IG, Saini M, DiMeco F, Prada F. Advanced Ultrasound Imaging in Glioma Surgery: Beyond Gray-Scale B-mode. Front Oncol. 2018 Dec 3;8:576. doi: 10.3389/fonc.2018.00576. eCollection 2018.
citation: D'Amico RS, Englander ZK, Canoll P, Bruce JN. Extent of Resection in Glioma-A Review of the Cutting Edge. World Neurosurg. 2017 Jul;103:538-549. doi: 10.1016/j.wneu.2017.04.041. Epub 2017 Apr 17.
citation: Hervey-Jumper SL, Berger MS. Maximizing safe resection of low- and high-grade glioma. J Neurooncol. 2016 Nov;130(2):269-282. doi: 10.1007/s11060-016-2110-4. Epub 2016 May 12.