[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"net\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:net":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100617499","dceus-to-assess-treatment-response-to-prrt-in-gep-net-100617499",false,"NCT07319416","DCEUS to Assess Treatment Response to PRRT in GEP-NET","Role of Dynamic Contrast-enhanced Ultrasound (D-CEUS) in Assessment of Response to Radioreceptor Therapy (PRRT) in Patients With Pancreatic and Gastrointestinal Tract Neuroendocrine Tumors (GEP-NET)","DCEUS-PRRT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed diagnosis of unresectable, well-differentiated GEP-NET G2 or G3 according to WHO 2019 Classification with a Ki67 index \\> 2% up to 55%.\n* Somatostatin receptor-positive (SSTR+) disease defined by a homogenous SSTRs expression by SSA positive PET-CT or SPECT imaging.\n* At least one target lesion according to RECIST v1.1.\n* Participants must have signed and dated an approved written informed consent and must be able to comply with any study specific procedure.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Lutetium 177Lu - radionuclides.\n* Other known malignancies.\n* Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Neuroendocrine tumors (NETs) are a wide group of neoplasms arising from the diffuse neuroendocrine cell system that features significant molecular and biological heterogeneity. They mainly derive from the enterochromaffin cells of the gastroenteropancreatic tract (GEP-NETs) and their incidence and prevalence are steadily rising, possibly as a consequence of improving diagnostic methods and earlier detection. A major feature of GEP-NETs is their somatostatin receptor (SSTR) immunogenicity, which is relevant both for diagnostic and therapeutic purposes.\n\nFor patients with unresectable or advanced disease, systemic treatment is the standard of care. In this setting, Somatostatin analogues (SSAs) are the standard first line therapy and, even if response rates are low, disease progression is halted in about two thirds of patient. Recently, targeted radionuclide therapy has claimed significant attention as a valuable treatment option for many solid neoplasms. This approach relies on the administration of a radionuclide linked to a carrier-molecule that selectively interacts with tumor associated antigens, being eventually internalized and releasing β-radiation emission and low-energy γ rays directly from the inside of the cancer cells. Peptide Receptor Radionuclide Therapy (PRRT) is strongly recommended in progressive metastatic\u002Finoperable pretreated NETs that showed homogenous SSTRs expression by SSA positive PET-CT or single photon emission computed tomography (SPECT) imaging. Although PRRT is effective in the majority of cases, approximately 15-30% of patients will eventually progress during treatment. It is still challenging to distinguish potential responders versus non-responder patients. The identification of predictive biomarkers, apart from the required expression of somatostatin receptors, and of non-invasive diagnostic predictive exams, are an unmet need. Despite the promising clinical results, very little is known about the biological changes induced by PRRT on cancer tissue and tumor microenvironment and vascularization. The assessment of treatment' response therefore still relies on CT and PET-CT as markers of tumoral activity.\n\nAmong imaging modalities, ultrasound could play a key role in this setting. Indeed, contrast-enhanced ultrasound (CEUS) allows a thorough assessment of tumor perfusion through analysis of both contrast media flow pattern and time-intensity curves. This quantitative analysis, called dynamic contrast enhanced ultrasound (DCE-US) is a novel technique that estimates tissue perfusion based on phase-specific enhancement after the injection of microbubble contrast agents. The parameters derived from this analysis could be used for treatment monitoring in oncology, as they are easily comparable through time in each patient. In order to establish the bases for standardization of DCE-US, the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) recently published an update on this topic.",[27,28,29],"NET","Radionucleide Therapy","Contrast Enhanced Ultrasound","RECRUITING","2025-12-21",{"date":33,"type":34},"2026-01-06","ACTUAL",{"date":36,"type":34},"2025-12-11",{"date":38,"type":21},"2027-10-01",{"name":40,"class":41},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100515864","phase-2-trial-of-nab-sirolimus-in-patients-with-well-differentiated-neuroendocrine-tumors-nets-of-the-gastrointestinal-tract-lung-or-pancreas-who-have-not-received-prior-treatment-with-mtor-inhibitors-100515864","NCT05997056","Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors","A Phase 2 Multi-center, Open-label, Single Arm Study of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors","Inclusion Criteria:\n\n1. Patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received 2 or less prior lines of therapy excluding somatostatin analogs\n2. Patients with functional NETs may enroll if:\n\n   1. the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and\n   2. the patient has experienced disease progression while on stable somatostatin analogs dose\n3. Patients must have 1 or more measurable target lesions by RECIST v1.1\n4. Age: 18 years or older\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80\n6. Adequate liver function:\n\n   1. Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome or attributable to liver metastases, then ≤3 × ULN)\n   2. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)\n7. Adequate renal function: creatinine clearance ≥30 mL\u002Fmin, Cockcroft-Gault creatinine clearance = ((140-age) × weight\\[kg\\]) \u002F (72 × serum creatinine \\[mL\u002Fmin\\]) × 0.85, if female.\n8. Adequate hematologic parameters:\n\n   1. Absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL (growth factor support allowed)\n   2. Platelet count ≥100,000\u002Fmm\\^3 (100 × 10\\^9\u002FL) (transfusion and\u002For growth factor support allowed)\n   3. Hemoglobin ≥8.0 g\u002FdL (transfusion and\u002For growth factor support allowed)\n9. Fasting serum triglyceride must be ≤300 mg\u002FdL; fasting serum cholesterol must be less than or equal to 350 mg\u002FdL\n10. Minimum of 4 weeks since any major surgery, completion of radiation, and adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1\n11. Male or non-pregnant and non-breastfeeding female:\n\n    1. Females of childbearing potential must agree to use effective contraception or abstinence without interruption from 28 days prior to starting study medication throughout 3 months after last dose of study medication and have a negative serum pregnancy test (beta human chorionic gonadotropin \\[β-hCG\\]) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the EOS treatment. A second form of birth control is required even if she has had a tubal ligation.\n    2. Male patients must agree not to donate sperm and must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last dose of study medication. A second form of birth control is required even if he has undergone a successful vasectomy.\n    3. Sexual abstinence is considered a highly effective contraceptive method only if defined as refraining from heterosexual intercourse from 28 days prior to starting study medication throughout 3 months after last dose of study medication. The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.\n12. The patient or the patient's legal guardian(s) understand(s) and sign(s) the informed consent\n13. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n14. Patients with a known history of human immunodeficiency virus (HIV) infection are eligible if:\n\n    1. There has been no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection in 12 months prior to enrollment.\n    2. The patient has been receiving an antiretroviral therapy regimen for ≥4 weeks and the HIV viral load is \\\u003C400 copies\u002FmL prior to enrollment.\n    3. Antiretroviral therapy regimen does not include strong cytochrome (CYP)3A4 inhibitors or inducers\n\nExclusion Criteria:\n\n1. Prior treatment with mTOR inhibitors including nab-sirolimus\n\n   Note: Patients who have previously received locoregional or liver-directed therapies (radiofrequency or microwave ablation, transarterial chemoembolization, etc.) are eligible to enroll in the study.\n2. Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor\n3. Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)\n4. Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment\n5. Patients who have any severe and\u002For uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:\n\n   1. Known or suspected brain metastases\n   2. Severe heart disease defined as unstable angina pectoris, NYHA Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.\n   3. Severe lung disease defined as a diffusing capacity for carbon monoxide that is ≤50% of normal predicted value and\u002For an O2 saturation ≤88% at rest on room air\n\n      (Note: Spirometry and pulmonary function tests are not required to be performed unless clinically indicated.)\n   4. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy\n   5. A history of malignancies other than the one under treatment unless the patient is disease-free for more than 5 years from diagnosis. Controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low-grade hematologic malignancies (eg, chronic lymphocytic leukemia, follicular lymphoma, etc), or other adequately treated carcinoma in situ may be eligible, after discussion with the medical monitor.\n   6. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg)\n   7. Patients with history of interstitial lung disease and\u002For pneumonitis, or pulmonary hypertension\n   8. Active Hepatitis B and\u002For Hepatitis C infection and detectable viral load despite antiviral therapy.\n6. Required use of concomitant medications with strong CYP3A4 interactions (induction or inhibition) should be discontinued (strong inhibitors include ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, telithromycin; strong inducers include rifampin and rifabutin). These agents must be discontinued prior to first dose of nab-sirolimus.",{"count":51,"type":21},21,[53],"PHASE2","A Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors",[56,27,57,58,59],"Neuroendocrine Tumors","Pancreatic Neuroendocrine Tumor","Gastrointestinal Neuroendocrine Tumor","Pulmonary Neuroendocrine Tumor",[61,62,63,56,27,57,58,59],"FYARRO","nab-sirolimus","ABI-009","2024-07-15",{"date":66,"type":34},"2024-07-16",{"date":68,"type":34},"2023-11-07",{"date":70,"type":21},"2025-12-08",{"name":72,"class":73},"Aadi Bioscience, Inc.","INDUSTRY",4]