Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-31 @ 4:08 AM
Study NCT ID:
NCT06263361
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI imaging', 'timeFrame': 'Baseline (before surgery)', 'description': 'Peritumoral area (PTA) volumes in T1w sequence Units: cm3.'}, {'measure': 'MRI imaging', 'timeFrame': 'Baseline (before surgery)', 'description': 'Peritumoral area (PTA) volumes in T2w sequence. Units: cm3.'}, {'measure': 'MRI imaging', 'timeFrame': 'Baseline (before surgery)', 'description': 'Peritumoral area (PTA) volumes in FLAIR sequence. Units: cm3.'}, {'measure': 'MRI imaging', 'timeFrame': 'Baseline (before surgery)', 'description': 'Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s'}, {'measure': 'Define immunopathological features', 'timeFrame': '1 week after surgical procedure', 'description': 'Number of immune cells infiltrating the lesion. Units: number/mm3'}], 'secondaryOutcomes': [{'measure': 'Accuracy of fluoresceine guided stereotactic biopsy', 'timeFrame': '1 week after surgical procedure', 'description': 'Number of patients with samples positively stained with fluoresceine. Units: number of samples/patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Lymphoma']}, 'referencesModule': {'references': [{'pmid': '31632903', 'type': 'BACKGROUND', 'citation': 'Akshulakov SK, Kerimbayev TT, Biryuchkov MY, Urunbayev YA, Farhadi DS, Byvaltsev VA. Current Trends for Improving Safety of Stereotactic Brain Biopsies: Advanced Optical Methods for Vessel Avoidance and Tumor Detection. Front Oncol. 2019 Oct 2;9:947. doi: 10.3389/fonc.2019.00947. eCollection 2019.'}, {'pmid': '19729544', 'type': 'BACKGROUND', 'citation': 'Barajas RF Jr, Rubenstein JL, Chang JS, Hwang J, Cha S. Diffusion-weighted MR imaging derived apparent diffusion coefficient is predictive of clinical outcome in primary central nervous system lymphoma. AJNR Am J Neuroradiol. 2010 Jan;31(1):60-6. doi: 10.3174/ajnr.A1750. Epub 2009 Sep 3.'}, {'pmid': '33560416', 'type': 'BACKGROUND', 'citation': 'Barajas RF, Politi LS, Anzalone N, Schoder H, Fox CP, Boxerman JL, Kaufmann TJ, Quarles CC, Ellingson BM, Auer D, Andronesi OC, Ferreri AJM, Mrugala MM, Grommes C, Neuwelt EA, Ambady P, Rubenstein JL, Illerhaus G, Nagane M, Batchelor TT, Hu LS. Consensus recommendations for MRI and PET imaging of primary central nervous system lymphoma: guideline statement from the International Primary CNS Lymphoma Collaborative Group (IPCG). Neuro Oncol. 2021 Jul 1;23(7):1056-1071. doi: 10.1093/neuonc/noab020.'}, {'pmid': '30344041', 'type': 'BACKGROUND', 'citation': 'Harris N, Fetter RD, Brasier DJ, Tong A, Davis GW. Molecular Interface of Neuronal Innate Immunity, Synaptic Vesicle Stabilization, and Presynaptic Homeostatic Plasticity. Neuron. 2018 Dec 5;100(5):1163-1179.e4. doi: 10.1016/j.neuron.2018.09.048. Epub 2018 Oct 18.'}, {'pmid': '23091408', 'type': 'BACKGROUND', 'citation': 'Chen B, Wang H, Ge P, Zhao J, Li W, Gu H, Wang G, Luo Y, Chen D. Gross total resection of glioma with the intraoperative fluorescence-guidance of fluorescein sodium. Int J Med Sci. 2012;9(8):708-14. doi: 10.7150/ijms.4843. Epub 2012 Oct 6.'}, {'pmid': '29018053', 'type': 'BACKGROUND', 'citation': 'Acerbi F, Broggi M, Schebesch KM, Hohne J, Cavallo C, De Laurentis C, Eoli M, Anghileri E, Servida M, Boffano C, Pollo B, Schiariti M, Visintini S, Montomoli C, Bosio L, La Corte E, Broggi G, Brawanski A, Ferroli P. Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO). Clin Cancer Res. 2018 Jan 1;24(1):52-61. doi: 10.1158/1078-0432.CCR-17-1184. Epub 2017 Oct 10.'}, {'pmid': '26895208', 'type': 'BACKGROUND', 'citation': 'Hamamcioglu MK, Akcakaya MO, Goker B, Kasimcan MO, Kiris T. The use of the YELLOW 560 nm surgical microscope filter for sodium fluorescein-guided resection of brain tumors: Our preliminary results in a series of 28 patients. Clin Neurol Neurosurg. 2016 Apr;143:39-45. doi: 10.1016/j.clineuro.2016.02.006. Epub 2016 Feb 11.'}, {'pmid': '18224529', 'type': 'BACKGROUND', 'citation': 'Koc 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.'}, {'pmid': '23851210', 'type': 'BACKGROUND', 'citation': 'Li Y, Rey-Dios R, Roberts DW, Valdes PA, Cohen-Gadol AA. Intraoperative fluorescence-guided resection of high-grade gliomas: a comparison of the present techniques and evolution of future strategies. World Neurosurg. 2014 Jul-Aug;82(1-2):175-85. doi: 10.1016/j.wneu.2013.06.014. Epub 2013 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings.', 'detailedDescription': 'Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. It is a relatively rare disorder, accounting for only 3% of all primary brain tumors but due to its anatomical localization represents an important clinical and diagnostic challenge in onco-hematology. different MRI patterns of the peritumoral area (PTA) might correlate with different histopathological sensitivity regarding diagnostic potential out of contrast-enhanced region (CER). Improvements in the understanding of PTA diagnostic potentials is of great help in diagnosing patients with deep-seated lesions, who would otherwise be not eligible for stereotactic biopsy and therefore for a consequent adequate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs at our Institution, able to express informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs\n\nExclusion Criteria:\n\n* Severe hepatic dysfunction\n* Severe renal dysfunction\n* Severe heart failure\n* myocardial infarction and stroke within 90 days\n* Hyperreactivity against contrast agents\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06263361', 'briefTitle': 'Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma (PCNSL): Integration of Advanced MRI Patterns and Fluorescein Sodium Fluorescence', 'orgStudyIdInfo': {'id': 'NCH02-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Included patients', 'description': 'Adult patients (\\>18 years) candidates to stereotactic biopsy for histopathological diagnosis of intra-axial lesions suspected for primary central nervous system lymphoma (PCNSLs).', 'interventionNames': ['Diagnostic Test: MRI imaging', 'Diagnostic Test: Cerebral biopsy']}], 'interventions': [{'name': 'MRI imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.', 'armGroupLabels': ['Included patients']}, {'name': 'Cerebral biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.', 'armGroupLabels': ['Included patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Sincinelli', 'role': 'CONTACT', 'email': 'sincinelli.laura@hsr.it', 'phone': '003926435568'}], 'facility': 'IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Laura Sincinelli', 'role': 'CONTACT', 'email': 'sincinelli.laura@hsr.it', 'phone': '+390226435568'}], 'overallOfficials': [{'name': 'Pietro Mortini, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS San Raffaele Scientific Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Department', 'investigatorFullName': 'Pietro Mortini, MD, Prof.', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}