Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 9:23 AM
Study NCT ID:
NCT06830356
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2037-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2037-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of brain radionecrosis', 'timeFrame': 'up to 13 years', 'description': 'Incidence of symptomatic brain radionecrosis (grade \\>=2 defined according to CTCAE scale v5.0).'}, {'measure': 'Assess progression free survival (progression free survival = PFS) at 3 years', 'timeFrame': 'up to 13 years', 'description': 'Percentage of patients alive and free of disease progression at 3 years after the start of radiotherapy (PFS rate). Progression will be defined as increase in size of treated lesions or appearance of new lesions (according to RANO meningioma criteria)'}], 'secondaryOutcomes': [{'measure': 'Overall survival (Overall survival = OS)', 'timeFrame': 'up to 13 years', 'description': 'Overall survival (OS) will be defined as time between enrollment and death'}, {'measure': 'Incidence of other toxicities', 'timeFrame': 'up to 13 years', 'description': 'Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0'}, {'measure': 'Concordance between GTV-RM and GTV-PET', 'timeFrame': 'up to 13 years', 'description': 'Concordance will be measured according to Dice Similarity coefficient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningioma']}, 'descriptionModule': {'briefSummary': 'High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 16 years;\n* Ability to express appropriate informed consent to treatment;\n* Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;\n* In case of recurrence, confirmation can be either histological or radiological;\n* Not previous brain-level radiotherapy;\n* Performance status: ECOG=0-2.\n\nExclusion Criteria:\n\n* Refusal to radiation treatment (i.e., absence of signed informed consent);\n* Other concomitant oncologic therapies\n* Current pregnancy;\n* Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;\n* Inability to perform MRI with MoC or PET.'}, 'identificationModule': {'nctId': 'NCT06830356', 'acronym': 'SPIDER-MEN', 'briefTitle': 'Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.', 'organization': {'class': 'OTHER', 'fullName': 'Centro di Riferimento Oncologico - Aviano'}, 'officialTitle': 'Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.', 'orgStudyIdInfo': {'id': 'CRO-2024-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation of radiation therapy, based on somatostatin receptor PET imaging', 'description': 'Radiation treatment with higher doses than the standard and defined using PET imaging', 'interventionNames': ['Radiation: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging']}], 'interventions': [{'name': 'Dose escalation of radiation therapy, based on somatostatin receptor PET imaging', 'type': 'RADIATION', 'description': 'Radiation treatment with higher doses than the standard and defined using PET imaging', 'armGroupLabels': ['Dose escalation of radiation therapy, based on somatostatin receptor PET imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Vinante, MD', 'role': 'CONTACT'}, {'name': 'Maurizio Mascarin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro di Riferimento Oncologico di Aviano (CRO)', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}], 'centralContacts': [{'name': 'Lorenzo Vinante', 'role': 'CONTACT', 'email': 'lorenzo.vinante@cro.it', 'phone': '0434 659855'}, {'name': 'Maurizio Mascarin', 'role': 'CONTACT', 'email': 'mascarin@cro.it'}], 'overallOfficials': [{'name': 'Lorenzo Vinante', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro di Riferimento Oncologico di Aviano (CRO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}