[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652621":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":35,"responsibleParty":63,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"N.N. Petrov National Medical Research Center of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard-of-Care Group (Control Group)",null,"Patients in the control group will undergo standard diagnostic and therapeutic management according to current clinical practice. Following radical inguinal orchiectomy and histopathological assessment, each patient's case will be reviewed by a multidisciplinary tumor board. Subsequent management, including active surveillance, systemic chemotherapy, radiotherapy, or other treatment when indicated, will be determined according to the pathological findings, clinical stage, and applicable clinical guidelines.",[13],"Procedure: Standard treatment: orchiectomy followed by drug therapy and, if necessary, retroperitoneal lymphadenectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"SLNB Group (Investigational Group)","Patients in the investigational group will undergo sentinel lymph node mapping using technetium-99m (Tc-99m) and indocyanine green (ICG). Preoperative lymphatic mapping will be performed using SPECT\u002FCT following administration of the Tc-99m-labelled radiopharmaceutical. During minimally invasive surgery, sentinel lymph nodes will be identified using gamma detection and near-infrared fluorescence imaging following ICG administration. Identified sentinel lymph nodes will be removed and subjected to histopathological and immunohistochemical examination. Retroperitoneal lymph node dissection will be performed according to the study protocol and the patient's clinical stage. Radical inguinal orchiectomy will subsequently be performed, and all surgical specimens will undergo histopathological examination.",[18],"Procedure: sentinel lymph node mapping using technetium-99m (Tc-99m) and indocyanine green (ICG) with subsequent orchiectomy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Standard treatment: orchiectomy followed by drug therapy and, if necessary, retroperitoneal lymphadenectomy","Patients assigned to the control group will receive standard-of-care treatment in accordance with current clinical guidelines and institutional practice.\n\nPatients will initially undergo radical inguinal orchiectomy (orchifuniculectomy) with subsequent histopathological examination of the surgical specimen. Following confirmation of the diagnosis and assessment of the pathological and clinical stage, each patient's case will be reviewed by a multidisciplinary tumor board to determine the appropriate further treatment strategy.\n\nDepending on the clinical stage, pathological findings, prognostic factors, and multidisciplinary tumor board decision, patients will receive standard systemic anticancer therapy, including platinum-based chemotherapy when indicated.\n\nFollowing systemic treatment, patients will undergo clinical and radiological response assessment. Retroperitoneal lymph node dissection (RPLND) may be performed when clinically indicated based on residual retroperitoneal disease,",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"sentinel lymph node mapping using technetium-99m (Tc-99m) and indocyanine green (ICG) with subsequent orchiectomy","Patients enrolled in the investigational group will undergo dual-tracer sentinel lymph node mapping and sentinel lymph node biopsy (SLNB) using a technetium-99m (Tc-99m)-labelled radiopharmaceutical and indocyanine green (ICG), followed by retroperitoneal lymph node dissection (RPLND) and radical inguinal orchiectomy.\n\nRadiopharmaceutical Administration\n\nApproximately 24 hours before surgery, patients will undergo administration of a Tc-99m-labelled colloidal radiopharmaceutical. Under ultrasound guidance using a high-frequency linear transducer, 0.2 mL of the radiopharmaceutical, with an activity of 740-860 MBq and a particle size of approximately 1,000 nm, will be injected beneath the tunica albuginea in the projection of the primary testicular tumor. The radiopharmaceutical will be prepared immediately before administration.\n\nPreoperative SPECT\u002FCT and Sentinel Lymph Node Mapping\n\nApproximately 3 hours after radiopharmaceutical administration, radionuclide imaging of the lymphatic dr",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Mariya Berkut, PhD","CONTACT","+ 7 9312870497","berkutv91@gmail.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"FSBI \"N.N. Petrov NMRC of oncology\" MH of Russian Federation","RECRUITING","Saint Petersburg","Sankt-Peterburg","197758","Russia","RU",{"type":45,"coordinates":46},"Point",[47,48],30.31413,59.93863,{"lat":48,"lon":47},[51,54,58,61],{"name":52,"role":32,"phone":53,"phoneExt":10,"email":34},"Mariia Berkut, PhD","89312870497",{"name":55,"role":32,"phone":56,"phoneExt":10,"email":57},"Pavel Gorlin","+79538151173","gorlin23@yandex.ru",{"name":59,"role":60,"phone":10,"phoneExt":10,"email":10},"Alexander Nosov, PhD, Professor","PRINCIPAL_INVESTIGATOR",{"name":55,"role":62,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":64,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100652621","sentinel-node-identification-using-gamma-and-near-infrared-imaging-in-testicular-malignancies-100652621",false,"NCT07777887","Sentinel Node Identification Using Gamma and Near-Infrared Imaging in TesticulAr MaLignancies","Sentinel Node Identification Using Gamma Detection and Near-Infrared Fluorescence in Testicular Malignancies","SIGNAL","Inclusion Criteria:\n\n* Presence of a primary testicular tumor suspicious for a testicular germ cell tumor (TGCT) and considered an indication for radical inguinal orchiectomy (orchifuniculectomy);\n* Male gender;\n* Maximum diameter of the primary testicular tumor (cT) ≤5 cm;\n* One of the following clinical nodal and serum tumor marker criteria:\n* \\- cN0 disease with serum tumor markers corresponding to S1 category: alpha-fetoprotein (AFP) 0-5.8 IU\u002FmL and β-human chorionic gonadotropin (β-hCG) \\>2.5 and \\\u003C1,000 IU\u002FmL; or\n* -cN1-cN2 disease, with no more than two radiologically suspicious retroperitoneal lymph nodes, and serum tumor markers corresponding to S0-S1 category;\n* No evidence of distant metastatic disease (cM0).\n* Patient refusal to undergo adjuvant anticancer treatment (chemotherapy or radiotherapy) following radical inguinal orchiectomy, or unwillingness\u002Finability to undergo close active surveillance.\n* Ability to understand the study requirements and provision of written voluntary informed consent prior to participation in the study.\n\nExclusion Criteria:\n\n* Maximum diameter of the primary testicular tumor (cT) \\>5 cm;\n* Presence of distant metastatic disease (cM1);\n* Serum tumor marker levels corresponding to S2-S3 category.\n* Clinical stage cN1 with ≥2 retroperitoneal lymph nodes suspicious for metastatic involvement;\n* Clinical stage cN3 disease;\n* Any previous specific anticancer treatment for a testicular germ cell tumor, including systemic chemotherapy, radiotherapy, or prior retroperitoneal surgery for testicular cancer;\n* Presence of any contraindication to minimally invasive surgery, administration of indocyanine green (ICG), or administration of the technetium-99m (Tc-99m)-labelled radiopharmaceutical used for sentinel lymph node mapping.","MALE","18 Years","60 Years",{"count":77,"type":78},60,"ESTIMATED","1 Year","OBSERVATIONAL","Testicular seminoma is a malignant tumor with a very high probability of cure. Current treatment approaches provide excellent long-term cancer outcomes. However, some standard treatments, including radiotherapy and platinum-based chemotherapy, may cause side effects both during treatment and many years after its completion. In the long term, these treatments may be associated with an increased risk of cardiovascular disease, metabolic disorders, and secondary malignancies.\n\nBecause most patients with seminoma are successfully cured and have a long life expectancy, an important goal of modern cancer treatment is not only to achieve effective cancer control, but also to reduce the potential long-term adverse effects of treatment.\n\nOne possible treatment approach is minimally invasive retroperitoneal lymph node dissection (RPLND), performed using laparoscopic or robot-assisted surgery. This procedure allows the disease stage to be determined more accurately by establishing whether cancer cells are present in the retroperitoneal lymph nodes. In some patients, surgery may potentially provide effective disease control without the need for subsequent radiotherapy or chemotherapy.\n\nHowever, currently available imaging methods, including computed tomography (CT), cannot always accurately determine whether individual retroperitoneal lymph nodes contain cancer cells. Studies have shown that in some patients undergoing RPLND for suspected lymph node involvement, no cancer cells are subsequently found in the removed lymph nodes. Therefore, there is a need to develop more accurate methods for identifying the lymph nodes that are most likely to be the first sites of cancer spread.\n\nWhy Are We Studying Sentinel Lymph Nodes?\n\nThis study investigates a method for identifying sentinel lymph nodes. Sentinel lymph nodes are the lymph nodes that first receive lymphatic drainage from the area of the primary tumor and may therefore be the first lymph nodes to which cancer cells spread.\n\nIn this study, two complementary methods will be used to identify sentinel lymph nodes. The first involves the administration of a small amount of a radiopharmaceutical containing technetium-99m (Tc-99m), followed by single-photon emission computed tomography combined with computed tomography (SPECT\u002FCT). During surgery, these lymph nodes will also be identified using a special gamma-detection device.\n\nThe second method involves the use of indocyanine green (ICG), a fluorescent dye that allows the surgeon to visualize lymphatic drainage pathways and lymph nodes during surgery using near-infrared fluorescence imaging.\n\nThe combination of these two methods may allow more accurate identification of sentinel lymph nodes and provide a better understanding of lymphatic drainage from testicular tumors.\n\nWhy Are You Being Invited to Participate?\n\nYou are being invited to participate because the characteristics of your disease meet the eligibility criteria for this study.\n\nThe main purpose of the study is to determine how accurately and reliably sentinel lymph nodes can be identified in patients with testicular seminoma using a combination of radionuclide and fluorescence-guided techniques.\n\nThe information obtained from this study may help to develop a more individualized approach to the surgical treatment of patients with seminoma. In the future, accurate identification of sentinel lymph nodes may make it possible to reduce the extent of surgery in selected patients, potentially decreasing surgical trauma and the risk of postoperative complications. At the same time, accurate detection of cancer involvement in lymph nodes may help identify patients who require additional anticancer treatment, such as systemic chemotherapy.\n\nIt is important to understand that the approach being evaluated is investigational, and its advantages over currently established approaches have not yet been conclusively demonstrated. Therefore, participation in this study cannot guarantee any additional direct medical benefit to you. However, the information obtained from your participation may contribute to improving the diagnosis and treatment of patients with testicular seminoma in the future.\n\nParticipation in this study is entirely voluntary. Before making your decision, you will have the opportunity to discuss the purpose of the study, the study procedures, possible benefits and risks, and alternative treatment options with your doctor. Your decision not to participate, or to withdraw from the study at a later time, will not affect your right to receive appropriate medical care.",[83],"Germ Cell Tumor of Testis",[85,86,87,88,89],"germ cell tumor","seminoma","sentinel node","Gamma Detection","minimal invasive surgery","2026-08-17",{"date":92,"type":93},"2026-08-20","ACTUAL",{"date":95,"type":93},"2026-04-01",{"date":97,"type":78},"2029-04-01",{"name":5,"class":6},1]