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

NCT ID: NCT05330559

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2024-04-08

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.

Conditions

Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Fluid MAX group

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro - Perin, MD - PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Neurologico Carlo Besta

Central Contacts

Alessandro Perin, MD -PhD

Role: CONTACT

alessandro.perin@istituto-besta.it

02-23942412

References

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Reference Type: BACKGROUND

PMID: 24285550 (View on PubMed)

Pino MA, Imperato A, Musca I, Maugeri R, Giammalva GR, Costantino G, Graziano F, Meli F, Francaviglia N, Iacopino DG, Villa A. New Hope in Brain Glioma Surgery: The Role of Intraoperative Ultrasound. A Review. Brain Sci. 2018 Nov 19;8(11):202. doi: 10.3390/brainsci8110202.

Reference Type: BACKGROUND

PMID: 30463249 (View on PubMed)

Mahboob S, McPhillips R, Qiu Z, Jiang Y, Meggs C, Schiavone G, Button T, Desmulliez M, Demore C, Cochran S, Eljamel S. Intraoperative Ultrasound-Guided Resection of Gliomas: A Meta-Analysis and Review of the Literature. World Neurosurg. 2016 Aug;92:255-263. doi: 10.1016/j.wneu.2016.05.007. Epub 2016 May 10.

Reference Type: BACKGROUND

PMID: 27178235 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29737540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29076783 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30560090 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28427971 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27174197 (View on PubMed)

Other Identifiers

FLUID-MAX

Identifier Type: -

Identifier Source: org_study_id