[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paraganglioma-phaeochromocytoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paraganglioma-phaeochromocytoma":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,87,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":50,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786",false,"NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","ALL","3 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[51,52,53,54,55,56,57,58,59,60,61,62,63,37,64,65,66,67,68,69,70,71,72,48,73],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","RECRUITING","2026-06-02",{"date":77,"type":78},"2026-06-04","ACTUAL",{"date":80,"type":78},"2024-09-20",{"date":82,"type":21},"2029-12",{"name":84,"class":85},"Fundación de investigación HM","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":115,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":86},"100598488","an-international-study-on-pediatric-patients-with-rare-tumors-100598488","NCT07072143","An International Study on Pediatric Patients With Rare Tumors.","The PARTNER Study - An International Prospective Observational Study on Pediatric Patients With Very Rare Tumors.","PARTNER","Inclusion Criteria:\n\n* Children and adolescents (age 0-18 years) with a primary or relapsed Very Rare Tumor diagnosed and\u002For treated in a participating country\u002Fcenter.\n* Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion Criteria:\n\n* Absence of Written informed consent from the patient and\u002For the parent\u002Flegal guardian","0 Years","18 Years",{"count":98,"type":21},6250,"OBSERVATIONAL","The PARTNER study is an international, prospective, observational study of paediatric patients with very rare tumours.",[47,102,103,104,105,106,107,108,109,110,111,112,113,114],"Melanoma and Other Malignant Neoplasms of Skin","Gastrointestinal Stromal Tumor (GIST)","Adrenocortical Tumor","Pancreatic Tumors","Esthesioneuroblastoma, Olfactory","Mesothelioma","Nasopharyngeal Carcinoma (NPC)","NUT Carcinoma","Pleuropulmonary Blastoma","Salivary Gland Tumors","Thymic Tumors","Thyroid Carcinoma","Appendiceal Cancers",[116,117,118,119,120],"children","rare tumors","very rare tumors","adolescents","PARTNER Study","2025-07-16",{"date":123,"type":78},"2025-07-18",{"date":125,"type":78},"2025-01-25",{"date":127,"type":21},"2049-06-06",{"name":129,"class":85},"Azienda Ospedaliera di Padova",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100525402","phase-2-trial-of-lu-177-dotatate-lutathera-in-unlicensed-indications-100525402","NCT06121271","Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications","Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications Including Bronchial and Thymic Neuroendocrine Tumour, Paraganglioma\u002FPhaeochromocytoma, Medullary Thyroid Carcinoma, and Repeat Peptide Receptor Radionuclide Therapy","Inclusion Criteria:\n\n1. Patients ≥18 years of age.\n2. Participants capable of giving informed consent\n3. Presence of unresectable or metastatic, well differentiated, somatostatin receptor positive non gastroenteropancreatic neuroendocrine tumours. Or for those having 2 cycles repeat therapy, GEP NET \\> 18 months from start of previous PRRT.\n4. Patients must have progressive disease based on RECIST Criteria, Version 1.1. In order to make the assessment, two CT (or MRI) scans are required. The oldest scan must not be older than 3 years from the date of enrolment. The most recent scan must not be older than 6 weeks from the date of enrolment.\n5. Confirmed presence of somatostatin receptors on all target lesions (for target\u002Fnon-target\u002Fmeasurable lesions definition see RECIST Criteria, Version 1.1) documented by CT\u002FMRI scans, based on positive OctreoScan or Ga68 Dotatate PET imaging within 24 weeks prior to enrolment in the trial.\n6. The tumour uptake observed in each target lesion (for target\u002Fnon-target\u002Fmeasurable lesions definition see RECIST Criteria, Version 1.1) using OctreoScan\u002FTc-99m-SRS should be ≥ normal liver uptake observed on planar imaging.\n7. The tumour uptake observed in each target lesion (for target\u002Fnon-target\u002F measurable lesions definition see RECIST Criteria, Version 1.1) using Ga68 Dotatate PET should be ≥ normal liver uptake observed on PET imaging.\n8. KPS ≥60.\n9. Presence of at least 1 measurable site of disease on cross-sectional imaging.\n10. Females of childbearing potential (defined as \\\u003C2 years after last menstruation and not surgically sterile) and males, who are not surgically sterile or with female partners of childbearing potential must be willing to use a highly effective method of contraception during treatment and for a minimum of 6 months after the end of treatment (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:\n\n    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n    * oral\n    * intravaginal\n    * transdermal\n\n      * progestogen-only hormonal contraception associated with inhibition of ovulation\n    * oral\n    * injectable\n    * implantable\n\n      • intrauterine device (IUD)\n\n      • intrauterine hormone-releasing system (IUS)\n\n      • bilateral tubal occlusion\n\n      • vasectomised partner\n\n      • sexual abstinence\n      * Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to treatment initiation). NOTE: Participants are considered not of childbearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal. Inclusion Criteria for Subsequent Treatments\n\n1\\. Both serum creatinine ≤150 μmol\u002FL (≤1.7 mg\u002FdL) and calculated creatinine clearance ≥40 mL\u002Fmin, eventually confirmed by measured creatinine clearance (or measured GFR) using isotopic GFR measurement ≥40 mL\u002Fmin (the measured creatinine clearance\u002FGFR is required only as confirmatory exam).\n\n2\\. Haemoglobin concentration ≥5.0 mmol\u002FL (≥8.0 g\u002FdL); WBC ≥2 x109\u002FL (≥2000\u002Fmm3); platelets ≥75 x109\u002FL (≥75 x103\u002Fmm3).\n\n3\\. Total bilirubin ≤3x ULN. 4. Serum albumin \\>3.0 g\u002FdL, or serum albumin ≤3.0 g\u002FdL, but normal prothrombin time.\n\n5\\. KPS ≥60.\n\nExclusion Criteria:\n\n* Participants will not be eligible for trial participation if they meet any of the exclusion criteria, or will be discontinued at the discretion of the Investigator if they develop any of the exclusion criteria during the trial.\n\nExclusion Criteria at Baseline\n\n1. Either serum creatinine \\>150 μmol\u002FL (\\>1.7 mg\u002FdL), or calculated creatinine clearance \\\u003C40 mL\u002Fmin, eventually confirmed by measured creatinine clearance (or measured GFR using isotopic GFR measurement) \\\u003C40 mL\u002Fmin (the measured creatinine clearance\u002FGFR is required only as confirmatory exam).\n2. Haemoglobin concentration \\\u003C5.0 mmol\u002FL (\\\u003C8.0 g\u002FdL); WBC \\\u003C2 x109\u002FL (2000\u002Fmm3); platelets \\\u003C75 x109\u002FL (75 x103\u002Fmm3).\n3. Total bilirubin \\>3x upper limit of normal (ULN).\n4. Serum albumin \\\u003C3.0 g\u002FdL unless prothrombin time is within the normal range.\n5. Pregnancy, planning a pregnancy or lactation.\n6. Any surgery, radioembolization, chemoembolization, chemotherapy, and radiofrequency ablation within 12 weeks prior to enrolment in the trial.\n7. Interferon, Everolimus (mTOR-inhibitors), or other systemic therapies within 4 weeks prior to enrolment in the trial.\n8. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to enrolment in the trial.\n9. Uncontrolled congestive heart failure (NYHA II, III, IV).\n10. Uncontrolled diabetes mellitus as defined by a fasting blood glucose \\>2x ULN.\n11. Any participant receiving treatment with short-acting Octreotide, which cannot be interrupted for 12 hours before and 24 hours after the administration of Lutathera, or any participant receiving treatment with Octreotide LAR or Lanreotide Autogel, which cannot be interrupted for at least 28 days before the administration of Lutathera, unless the tumour uptake observed on target and non-target but measurable lesions by OctreoScan or Ga68 Dotatate PET imaging during continued Octreotide LAR or Lanreotide Autogel treatment is at least as high as normal liver uptake observed by planar imaging (Kwekkeboom, Krenning et al. 2009).\n12. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the trial.\n13. Prior external beam radiation therapy to more than 25% of the bone marrow.\n14. Current spontaneous urinary incontinence.\n15. Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.\n16. Patients who have not provided a signed ICF to participate in the trial, obtained prior to the start of any protocol related activities.\n17. Patient with known incompatibility to CT Scans with IV contrast due to allergic reaction or renal insufficiency. If such participants can be imaged without the use of CT contrast material (ie, can tolerate MRI scans), such participants would not be excluded.\n18. Patients who have participated in any therapeutic clinical trial\u002Freceived any investigational agent within the last 30 days are excluded from participation in this trial.\n19. Patients with hypersensitivity to Lutathera (active substance or any of the excipients).\n20. Involved in the planning or conduct of this trial.\n21. Unwilling or unlikely to comply with the requirements of the trial. Exclusion Criteria for Subsequent Treatments\n\n1\\. Exclusion criteria for Baseline # 1, 2, 3, 4, and 10 apply to all subsequent treatments, when a relationship cannot be excluded with either trial drugs or the corresponding toxicity has not resolved.\n\n2\\. In relation to renal function, participants are also excluded from further therapy in case of \\>40% increase of serum creatinine over the baseline and with a concomitant decrease of \\>40% in creatinine clearance as calculated according to the Cockroft-Gault method, eventually confirmed by measured creatinine clearance (or GFR), if a relationship may not be excluded and the corresponding toxicity has not resolved.\n\n3\\. When such exclusion criteria events occur, the participant will postpone any subsequent trial treatment until resolution of the event (normalisation or return to baseline values). The participant remains in the trial and continues observation with the scheduled tumour and clinical assessments.\n\n4\\. All other exclusion criteria for enrolment eligibility apply to all subsequent treatments.",{"count":138,"type":21},110,[25],"This study is a phase 2, open, single-site trial. The primary objective of this study is to prospectively evaluate the safety and efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in unresectable or metastatic, somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications (eg, bronchial and thymic NET; paraganglioma\u002Fphaeochromocytoma; medullary thyroid carcinoma; and those requiring repeat peptide receptor radionuclide therapy (PRRT) with 2 further cycles of Lutathera). The aim is to recruit a total of 75-110 participants. Each patient will receive 4 cycles of Lutathera with 8-12 weeks time interval (except patients requiring repeat PRRT will receive 2 further cycles of Lutathera). The follow-up period will be for 2 years from the date of the last treatment.",[142,47,143,144],"Bronchial and Thymic Neuroendocrine Tumour","Medullary Thyroid Carcinoma","Those Requiring Repeat Peptide Receptor Radionuclide Therapy","NOT_YET_RECRUITING","2023-11-30",{"date":148,"type":78},"2023-12-07",{"date":150,"type":21},"2023-12-18",{"date":152,"type":21},"2027-11-06",{"name":154,"class":85},"University College, London"]