Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 10:48 PM
Study NCT ID:
NCT06869460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Retrospective Study on Patients Treated with Stereotactic Radiosurgery/Radiotherapy for Single Brain Lesions: Evaluation of Treatment Efficacy and Safety, Also Through Radiomic Analysis Methods.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 372}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity profile', 'timeFrame': 'due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment', 'description': '"The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."'}, {'measure': 'Local control', 'timeFrame': 'We will evaluate Lc at one, two, and five years from the treatment', 'description': "It will be Calculated 'per lesion,' and it is defined as the time interval between irradiation and the onset of disease recurrence at the site of the treated area"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain metastases', 'Radiotherapy', 'Stereotactic Body Radiotherapy', 'Radiosurgery', 'Radionecrosis', 'Local Control', 'Safety profile', 'Radiomics'], 'conditions': ['Brain Metastases', 'Radiotherapy Side Effect']}, 'descriptionModule': {'briefSummary': 'The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022', 'detailedDescription': 'The study will include patients of both sexes diagnosed with single brain metastases who underwent radiosurgical/stereotactic treatment. Attention will be paid to data related to local control, potential recurrence, and/or radionecrosis. Once a sufficient number of treated patients is reached, the feasibility of a radiomic feature analysis will be assessed in order to identify potential correlations and/or predictive values for treatment response or radionecrosis. If the sample size is adequate, participating centers will be asked to share pre- and post-RT MRI (brain MRI with contrast using thin slices) and treatment volumes for radiomic evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Treatment with SRS/SRT techniques for a single secondary brain lesion\n* Availability of pre-RT brain MRI with contrast (1mm slice thickness)\n* Availability of CT simulation imaging for treatment\n* Availability of relevant clinical data in the medical record for the study's objectives\n* Follow-up of at least 6 months after the completion of SRS or SRT\n* Follow-up evaluation through brain MRI\n\nExclusion Criteria:\n\n* Age under 18 years\n* Lack of clinical/radiological data for the patient\n* Unavailability of the required imaging\n* Previous whole-brain radiotherapy treatment"}, 'identificationModule': {'nctId': 'NCT06869460', 'acronym': 'STEREOMIC', 'briefTitle': 'Multicenter Retrospective Study on Patients Treated with Stereotactic Radiosurgery/Radiotherapy for Single Brain Lesions: Evaluation of Treatment Efficacy and Safety, Also Through Radiomic Analysis Methods.', 'organization': {'class': 'OTHER', 'fullName': 'Gemelli Molise Hospital'}, 'officialTitle': 'STEREOMIC: Studio Retrospettivo Multicentrico Su Pazienti Trattati Con Radiochirurgia/Radioterapia STEREotassica Per Lesioni Encefaliche Singole. Valutazione Di Efficacy E Safety Del Trattamento Anche Mediante Metodiche Di Analisi RadiOMICa', 'orgStudyIdInfo': {'id': 'CET20-02-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a singular brain metastases', 'description': 'The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy/Radiosurgery']}], 'interventions': [{'name': 'Stereotactic Body Radiotherapy/Radiosurgery', 'type': 'RADIATION', 'otherNames': ['SBRT/SRS'], 'description': 'Stereotactic Body Radiotherapy/Radiosurgery', 'armGroupLabels': ['Patients with a singular brain metastases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taranto', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Presidio Ospedaliero "S. G. Moscati"', 'geoPoint': {'lat': 40.46438, 'lon': 17.24707}}, {'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'INT IRCCS Fondazione G. Pascale Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80017', 'city': 'Campobasso', 'state': 'Molise', 'country': 'Italy', 'facility': 'Responsible Research Hospital', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}], 'overallOfficials': [{'name': 'Donato Pezzulla, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Responsible Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gemelli Molise Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}