[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649428":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":42,"collaborators":22,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":22,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":22,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[⁶⁸Ga]Ga-DLL3 Nanobody PET\u002FCT","EXPERIMENTAL","Participants receive a single intravenous injection of \\[⁶⁸Ga\\]Ga-DLL3 nanobody (a novel radiotracer targeting Delta-like ligand 3 \\[DLL3\\]), followed by whole-body PET\u002FCT imaging at approximately 2 hours post-injection. DLL3 is a protein aberrantly expressed on the surface of neuroendocrine tumor cells. The nanobody is engineered for high-affinity and specificity binding to DLL3, enabling non-invasive visualization of DLL3-expressing tumor lesions. The total injected protein mass and molar activity are controlled according to the study protocol to ensure consistent imaging quality. PET\u002FCT images are acquired from skull base to mid-thigh (extended to feet if clinically indicated) using a standardized acquisition protocol. Image reconstruction is performed with consistent algorithms across all participants. Each subject serves as their own control, with the DLL3 PET\u002FCT results compared to their conventional imaging (FDG PET\u002FCT or PSMA PET\u002FCT) performed within 2 weeks. The scan is performed",[13],"Drug: 68Ga-PFD3",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","68Ga-PFD3","\\[⁶⁸Ga\\]Ga-PFD3 is a novel PET tracer constructed by conjugating a DLL3-specific nanobody (single-domain antibody, \\~15 kDa) with a chelator for ⁶⁸Ga radiolabeling. DLL3 (Delta-like ligand 3) is a cell-surface protein that is rarely expressed in healthy adult tissues but is overexpressed in over 80% of small cell lung cancer and in other high-grade neuroendocrine tumors, making it an attractive target for molecular imaging. The nanobody platform offers advantages over conventional monoclonal antibody-based tracers (e.g., \\[⁸⁹Zr\\]Zr-DFO-SC16.56): smaller size (\\~15 kDa vs. \\~150 kDa) enables superior tissue penetration, rapid blood clearance, and shorter in vivo residence time, allowing same-day PET\u002FCT imaging within hours post-injection.\n\nParticipants receive a single intravenous injection of \\[⁶⁸Ga\\]Ga-PFD3 (activity: 111-185 MBq; protein mass and molar activity controlled per protocol), followed by whole-body PET\u002FCT acquisition at approximately 2 hours post-injection. Images are acquired from",[9],[21],"68Ga-DLL3",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Tingting Yuan, MD","CONTACT","+86 13051707479","biluohtt@163.com",[30],{"facility":5,"status":22,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":22},"Beijing","Beijing Municipality","100034","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Tingting Yuan","Postdoctoral Fellow; Attending Physician","100649428","phase-2-comparing-dll3-petct-to-standard-scans-in-neuroendocrine-cancer-100649428",false,"NCT07733024","Comparing DLL3 PET\u002FCT to Standard Scans in Neuroendocrine Cancer","A Prospective, Multi-Center, Self-Controlled Phase IIa Clinical Trial Evaluating the Diagnostic Performance and Clinical Impact of [⁶⁸Ga]Ga-DLL3 Nanobody PET\u002FCT Compared to [¹⁸F]FDG or [⁶⁸Ga]Ga-PSMA PET\u002FCT in Patients With Metastatic Neuroendocrine Neoplasms","DSC-NEC","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 80 years at the time of signing the informed consent form, male or female.\n* Histologically or cytologically confirmed neuroendocrine neoplasms (NENs), including but not limited to small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), gastroenteropancreatic neuroendocrine tumors (GEP-NENs), or other NEN subtypes.\n* Patients with strong clinical and radiological suspicion of NENs based on imaging (CT\u002FMRI\u002Fconventional PET\u002FCT) and clinical presentation.\n* At least 2 evaluable metastatic lesions (multiple metastases) confirmed by conventional imaging (CT\u002FMRI\u002FPET\u002FCT).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy \\> 3 months.\n* Voluntarily agrees to participate and provides written informed consent.\n* Females of childbearing potential and male participants agree to use reliable contraceptive methods for 6 months after the last study drug administration.\n* Willing and able to comply with scheduled visits, diagnostic procedures, clinical laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Known severe immediate-type hypersensitivity or anaphylactic reaction to DLL3-targeted tracers, nanobody proteins, chelators, buffer components, or excipients.\n* Pregnant or breastfeeding women.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m².\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN).\n* Total bilirubin \\> 1.5 × ULN.\n* Inability to tolerate or cooperate with PET\u002FCT imaging procedures, including but not limited to: severe claustrophobia, inability to remain supine and still for at least 30 minutes, or inability to establish adequate intravenous access.\n* Received chemotherapy, biological therapy, endocrine therapy, molecular targeted therapy, or investigational drug therapy within 4 weeks prior to enrollment.\n* Currently participating in another interventional clinical trial.\n* Prior exposure to any DLL3-targeted therapeutic agent (e.g., Tarlatamab, bispecific T-cell engagers, or DLL3-targeted radioimmunotherapy) or DLL3-targeted radiotracer.\n* Prior radionuclide therapy or diagnostic scan with an interval of less than 10 physical half-lives of the administered radionuclide prior to study tracer administration.\n* History of any other malignancy within 5 years prior to screening, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies with negligible risk of recurrence in the investigator's opinion.\n* Clinically significant abnormalities on physical examination, electrocardiogram (ECG), or clinical laboratory tests during screening that, in the investigator's opinion, may compromise safety or study compliance.\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for study participation (e.g., severe psychiatric disorders, substance abuse, poor compliance).","ALL","18 Years","80 Years",{"count":58,"type":59},200,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This study is testing a new PET\u002FCT scan that uses a special tracer called \\[⁶⁸Ga\\]Ga-DLL3 nanobody to see if it can better detect cancer spread (metastases) in people with neuroendocrine tumors than the standard scans currently used (FDG PET\u002FCT or PSMA PET\u002FCT). DLL3 is a protein found on the surface of many neuroendocrine tumor cells, and the new tracer is designed to stick to this protein, making tumors visible on the scan. The goal is to find out whether this new imaging method can give doctors more accurate information about where the cancer has spread and help them choose the most appropriate treatment for each patient.\n\nThe study is prospective, multi-center, and self-controlled, meaning each participant will receive both the new scan and the standard scan, allowing a direct side-by-side comparison in the same person. Depending on the type of neuroendocrine tumor, participants will be assigned to one of two groups: one group will be compared with FDG PET\u002FCT and the other with PSMA PET\u002FCT. The two scans will be performed within two weeks of each other, and all images will be read by independent experts who do not know the patient's clinical history, to ensure objective and unbiased results.\n\nThe investigators plan to enroll about 180-200 patients aged 18 or older who have confirmed neuroendocrine tumors with at least two metastatic sites. The total duration of participation is approximately 6 months, consisting of a screening period of up to 14 days, two imaging scans completed within 2 days, and a final follow-up visit at 6 months to evaluate participants' health and disease progression. Participation is entirely voluntary, and participants may withdraw at any time without affecting participants' standard medical care.",[65],"Neuroendocrine Tumors",[65,67,68,69],"[⁶⁸Ga]Ga-DLL3 Nanobody","DLL3 expression","Comparative Study","NOT_YET_RECRUITING","2026-07-28",{"date":73,"type":74},"2026-07-29","ACTUAL",{"date":76,"type":59},"2026-07-06",{"date":78,"type":59},"2028-12-31",{"name":44,"class":6},1]