Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT05330559
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2022-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-04-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'third Outcome', 'timeFrame': 'year 2', 'description': 'compare the performance of the new Glow400 fluorescence technique with the traditional FL400 in identifying tumor infiltration with respect to the examination histopathology'}, {'measure': 'fourth Outcome', 'timeFrame': 'year 2', 'description': 'identify histological and / or genetic characteristics capable of influencing the performance of margin assessment techniques'}], 'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': 'year 2', 'description': 'Evaluation of Sensitivity and Specificity of individual techniques (bright field observation, 5-ALA FGS and ioUS) in detecting tumor infiltration quantified by histopathological examination.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': 'year 2', 'description': 'Conduct a feasibility study on the use of the above techniques in sequence described;'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '24285550', 'type': 'BACKGROUND', 'citation': 'Chaichana KL, Jusue-Torres I, Navarro-Ramirez R, Raza SM, Pascual-Gallego M, Ibrahim A, Hernandez-Hermann M, Gomez L, Ye X, Weingart JD, Olivi A, Blakeley J, Gallia GL, Lim M, Brem H, Quinones-Hinojosa A. Establishing percent resection and residual volume thresholds affecting survival and recurrence for patients with newly diagnosed intracranial glioblastoma. Neuro Oncol. 2014 Jan;16(1):113-22. doi: 10.1093/neuonc/not137. Epub 2013 Nov 26.'}, {'pmid': '30463249', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27178235', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29737540', 'type': 'BACKGROUND', '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.'}, {'pmid': '29076783', 'type': 'BACKGROUND', '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.'}, {'pmid': '30560090', 'type': 'BACKGROUND', '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.'}, {'pmid': '28427971', 'type': 'RESULT', '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."}, {'pmid': '27174197', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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)', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by HGGs', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients 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.\n\nExclusion Criteria:\n\n* Patients aged less than 18 years at the time of radiological diagnosis\n* Patients who have received radiation therapy in the same area as the neoplasm of interest\n* Patients contraindicated to 5-ALA administration\n* Patients whose neoplasm is in close proximity to functionally eloquent areas (Primary Motor, Broca's, Wernicke's areas)\n* Patients who have not given their consent to take part in the research"}, 'identificationModule': {'nctId': 'NCT05330559', 'acronym': 'FLUID-MAX', 'briefTitle': 'Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta'}, 'officialTitle': 'Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection', 'orgStudyIdInfo': {'id': 'FLUID-MAX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluid MAX group', 'type': 'OTHER', 'description': '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)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alessandro Perin, MD -PhD', 'role': 'CONTACT', 'email': 'alessandro.perin@istituto-besta.it', 'phone': '02-23942412'}], 'overallOfficials': [{'name': 'Alessandro - Perin, MD - PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Istituto Neurologico Carlo Besta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}