[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581806":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":12,"centralContacts":12,"locations":29,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":12,"enrollmentInfo":63,"targetDuration":12,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":32,"whyStopped":12,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"2A - LA-SSA injection 4-6 weeks before PRRT","ACTIVE_COMPARATOR","In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.",[18],"Drug: Somatostatin analog",{"label":20,"type":21,"description":16,"interventionNames":22},"2B - LA-SSA injection 1-7 days before PRRT","EXPERIMENTAL",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DRUG","Somatostatin analog","Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).",[14,20],[30],{"facility":31,"status":32,"city":33,"state":12,"zip":12,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Antoni van Leeuwenhoek","RECRUITING","Amsterdam","Netherlands","NL",{"type":37,"coordinates":38},"Point",[39,40],4.88969,52.37403,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":12,"email":47},"Stokkel","CONTACT","+31205129111","ev.schouten@nki.nl",{"type":49,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[51],{"name":52,"class":53},"Neuroendocrine Tumor Research Foundation","UNKNOWN","100581806","phase-2-absorbed-tumor-dose-in-peptide-receptor-radionuclide-therapy-with-long-acting-somatostatin-analogues---atsa-trial-100581806",false,"NCT06855095","Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial","ATSA","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Able to provide spoken and written informed consent for the trial;\n* Histopathological confirmed neuroendocrine tumor;\n* Fulfill the clinical criteria for PRRT;\n* At least one soft tissue lesion \\> 2 cm;\n* Aimed administered activity of 7400 MBq;\n* ECOG score (performance status) 0-2.\n\nExclusion Criteria:\n\n* Not possible to discontinue LA-SSA for 4-6 weeks;\n* Use of short-acting SSAs;\n* Pregnancy and lactating female patients;\n* Inability to comply to the study procedures;\n* Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).","ALL","18 Years",{"count":64,"type":65},39,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE2","PHASE3","According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.",[72,73,74,75],"Neuroendocrine Tumors","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2","Neuroendocrine Neoplasm",[77,78,79,80],"Peptide Receptor Radionuclide Therapy","PRRT","Lutetium","DOTATATE","2025-02-26",{"date":83,"type":84},"2025-03-03","ACTUAL",{"date":86,"type":84},"2024-06-25",{"date":88,"type":65},"2027-03-01",{"name":5,"class":6},1]