Nctid:
NCT06614205
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008579", "term"=>"Meningioma"}], "ancestors"=>[{"id"=>"D000009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009383", "term"=>"Neoplasms, Vascular Tissue"}, {"id"=>"D000008577", "term"=>"Meningeal Neoplasms"}, {"id"=>"D000016543", "term"=>"Central Nervous System Neoplasms"}, {"id"=>"D000009423", "term"=>"Nervous System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M11562", "name"=>"Meningioma", "asFound"=>"Meningioma", "relevance"=>"HIGH"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12328", "name"=>"Neoplasms, Vascular Tissue", "relevance"=>"LOW"}, {"id"=>"M11560", "name"=>"Meningeal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12367", "name"=>"Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M18937", "name"=>"Central Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"T3707", "name"=>"Meningioma", "asFound"=>"Meningioma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M108723", "name"=>"Lutetium Lu 177 dotatate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>11}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-05-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-06-06", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Diagnostic accuracy for progression free survival", "timeFrame"=>"Day 1", "description"=>"Accuracy of tumor dosimetry to predict 6-month progression-free survival."}], "secondaryOutcomes"=>[{"measure"=>"Diagnostic accuracy for overal survival", "timeFrame"=>"Day 1", "description"=>"Accuracy of tumoral dosimetry in predicting 6-month overall survival"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["meningioma", "theragnostic", "dosimetry"], "conditions"=>["Meningioma of Brain"]}, "descriptionModule"=>{"briefSummary"=>"The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.", "detailedDescription"=>"Dosimetry is essential for Peptide Receptor Radionuclide Therapy (PRRT) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. Due to the increasing therapeutic applications of Lutathera, the European Association of Nuclear Medicine (EANM) recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues. Nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in Peptide Receptor Radionuclide Therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* patients treated for menigioma at nancy hospital\n* patients who performed 3 scintigraphics exams during there treatment\n\nExclusion Criteria:\n\n* patients deprived of liberty\n* patient who refused to collect data retrospectively"}, "identificationModule"=>{"nctId"=>"NCT06614205", "acronym"=>"DATUM", "briefTitle"=>"Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma", "organization"=>{"class"=>"OTHER", "fullName"=>"Central Hospital, Nancy, France"}, "officialTitle"=>"Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma", "orgStudyIdInfo"=>{"id"=>"2024PI102"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients treated with 177Lu-DOTATATE for meningioma", "description"=>"Patients treated with 177Lu-DOTATATE for meningioma at the Nancy's hospital who met the treatment criteria of the Compassionate Prescribing Framework and received a scintigraphy at D1, D4 and D7 (± 1 day)", "interventionNames"=>["Diagnostic Test: tumoral dosimetry by scintigraphy"]}], "interventions"=>[{"name"=>"tumoral dosimetry by scintigraphy", "type"=>"DIAGNOSTIC_TEST", "description"=>"The tumoral dosimetry has been done on patient after treatment by 177Lu-DOTATATE Theses patients performed a scintigraphy exam at D1, D4 and D7 after the treatment", "armGroupLabels"=>["Patients treated with 177Lu-DOTATATE for meningioma"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Boursier Caroline, MD", "role"=>"CONTACT", "email"=>"c.boursier@chru-nancy.fr", "phone"=>"+33383154276"}, {"name"=>"Véronique ROCH, MSC", "role"=>"CONTACT", "email"=>"v.roch@chru-nancy.fr", "phone"=>"+33383154276"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Central Hospital, Nancy, France", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"BOURSIER Caroline", "investigatorAffiliation"=>"Central Hospital, Nancy, France"}}}}
