[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":172,"collaborators":175,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":43,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":206,"whyStopped":43,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"188Re-SIRT","EXPERIMENTAL","The experimental arm will evaluate the safety, tolerability, biodistribution, and preliminary efficacy of indigenous 188Re-Microspheres for SIRT in unresectable HCC. Participants will be enrolled in three dosing cohorts (80-100 Gy, 100-150 Gy, 150-200 Gy) with 4 patients receiving 188Re-Microspheres per cohort. Pre-therapy assessments will include clinical evaluation, laboratory tests, serology, Child-Pugh score, AFP, portal vein status, and triple-phase CT\u002FMRI\u002FPET-CT. Lung shunt study using 99mTc-Microspheres will be performed on day of SIRT to calculate the 188Re-Microspheres activity required for intended dose. 188Re-Microspheres will be delivered via single femoral artery catheter under DSA, followed by post-therapy SPECT\u002FCT for biodistribution and dosimetry. Patients will be monitored for laboratory parameters, adverse events, and tumor response up to 12 weeks using mRECIST. Dose escalation will proceed only if dose-limiting toxicity is not observed in more than 1 of 3 patients.",[13],"Device: 188Re-Microspheres",{"label":15,"type":16,"description":17,"interventionNames":18},"90Y-SIRT","ACTIVE_COMPARATOR","The comparator arm aims to compare the safety, tolerability, biodistribution, and preliminary efficacy of 188Re-Microspheres with the standard-of-care 90Y-Microspheres for SIRT in unresectable HCC. Tumor dose escalation will be conducted in a phased manner across three groups receiving 80-100, 100-150, and 150-200 Gy. Prior to therapy, patients will undergo clinical evaluation, laboratory investigations, serological testing, and imaging with triple phase CT\u002FMRI\u002FPET-CT. 99mTc-MAA will be administered via trans-arterial catheter placed by femoral artery puncture under DSA at least one week prior to SIRT for lung shunt estimation and determination of the therapeutic dose of 90Y-Theraspheres. On the day of SIRT, the patient will be catheterized again, and the calculated Y90-Theraspheres dose will be delivered under DSA. Post-therapy PET-CT will be performed to assess biodistribution. Dose escalation will proceed only if dose-limiting toxicity is not observed in more than 1 of 3 patients.",[19],"Device: 90Y-Theraspheres",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","90Y-Theraspheres","Standard-of-care 90Y-Theraspheres will be delivered via femoral artery catheter under digital subtraction angiography (DSA) for intra-arterial SIRT. Pre-therapy angiographic mapping and 99mTc-MAA lung shunt study will be conducted at least one week before SIRT to delineate hepatic arterial anatomy, detect extrahepatic shunts, and determine lung shunt fraction for personalized dose calculation. On the day of therapy, the patient will undergo a second femoral artery catheterization, and the calculated 90Y-Theraspheres dose will be infused selectively into the hepatic artery supplying the tumor. Intra-procedural DSA imaging will monitor catheter position, stasis, and microsphere delivery. Post-therapy PET-CT will be performed to assess microsphere distribution. The absorbed doses to tumor, healthy liver and lungs will be estimated using partition method. Patients will be monitored for laboratory parameters, adverse events, and tumor response using mRECIST criteria up to 12 weeks.",[15],[27],"90Y-Glass microspheres",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"188Re-Microspheres","Indigenous 188Re-Microspheres will be administered via femoral artery catheter under DSA for intra-arterial SIRT. Pre-therapy angiographic mapping and lung shunt assessment using 99mTc-Microspheres will be performed on the same day to delineate hepatic arterial anatomy, detect extrahepatic shunts, and determine lung shunt fraction for administered activity estimation. The 188Re-Microspheres will be selectively infused into the hepatic artery supplying the tumor, with intra-procedural DSA monitoring for catheter placement and stasis. Post-therapy SPECT\u002FCT will be performed 24-48 hours after administration, allowing accurate confirmation of microsphere distribution and dosimetry, which is an advantage over standard 90Y-Theraspheres requiring separate pre- and post-procedure imaging. This single-session approach reduces procedural complexity and resource use. Patients will be monitored for laboratory parameters, adverse events, and tumor response using mRECIST criteria up to 12 weeks.",[9],[33],"188Re-Metal microspheres",[35],{"name":36,"affiliation":5,"role":37},"Jaya Shukla, Ph.D. Nuclear Medicine","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Prof. Jaya Shukla, Ph.D. Nuclear Medicine","CONTACT","+91-9781533400",null,"shuklajaya@gmail.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Prof. Naveen Kalra, MD Radiodiagnosis","+91 9855426320","navkal2004@yahoo.com",[50,79,102,125,147],{"facility":51,"status":43,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Postgraduate Institute of Medical Education and Research","Chandigarh","160012","India","IN",{"type":57,"coordinates":58},"Point",[59,60],76.7884,30.73629,{"lat":60,"lon":59},[63,64,65,67,70,71,73,75,77],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},{"name":66,"role":37,"phone":43,"phoneExt":43,"email":43},"Prof Jaya Shukla, Ph.D. Nuclear Medicine",{"name":68,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Ajay Duseja, DM Hepatology","SUB_INVESTIGATOR",{"name":46,"role":69,"phone":43,"phoneExt":43,"email":43},{"name":72,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Nusrat Shafiq, DM Clinical Pharmacology",{"name":74,"role":69,"phone":43,"phoneExt":43,"email":43},"Dr. Rajender Kumar, MD Nuclear Medicine",{"name":76,"role":69,"phone":43,"phoneExt":43,"email":43},"Dr. Harmandeep Singh, MD Nuclear Medicine",{"name":78,"role":69,"phone":43,"phoneExt":43,"email":43},"Dr. Harish Bhujade, MD Radiodiagnosis",{"facility":80,"status":43,"city":81,"state":82,"zip":83,"country":54,"countryCode":55,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Tata Memorial Hospital","Mumbai","Maharashtra","400012",{"type":57,"coordinates":85},[86,87],72.88261,19.07283,{"lat":87,"lon":86},[90,94,98,100],{"name":91,"role":41,"phone":92,"phoneExt":43,"email":93},"Prof. Venkatesh Rangarajan, DRM Nuclear Medicine","+91-9969014183","drvrangarajan@gmail.com",{"name":95,"role":41,"phone":96,"phoneExt":43,"email":97},"Prof. Ameya Puranik, DNB Nuclear medicine","+91-9619811125","ameya2812@gmail.com",{"name":99,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Venkatesh Rangarajan, MD Nuclear Medicine",{"name":101,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Ameya Puranik, DNB Nuclear Medicine",{"facility":103,"status":43,"city":104,"state":105,"zip":106,"country":54,"countryCode":55,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"All India Institute of Medical Sciences","Bhubaneswar","Odisha","751019",{"type":57,"coordinates":108},[109,110],85.83385,20.27241,{"lat":110,"lon":109},[113,117,121,122,123],{"name":114,"role":41,"phone":115,"phoneExt":43,"email":116},"Dr. Kanhaiyalal Agrawal, MD Nuclear Medicine","+91-8195930013","drkanis@gmail.com",{"name":118,"role":41,"phone":119,"phoneExt":43,"email":120},"Dr. Tara Prasad Tripathy, MD Radiodiagnosis","+91-8575827990","radiol_tara@aiimsbhubaneswar.edu.in",{"name":114,"role":37,"phone":43,"phoneExt":43,"email":43},{"name":118,"role":69,"phone":43,"phoneExt":43,"email":43},{"name":124,"role":69,"phone":43,"phoneExt":43,"email":43},"Dr. Manas Kumar Panigrahi, DM Gastroenterology",{"facility":126,"status":43,"city":127,"state":127,"zip":128,"country":54,"countryCode":55,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Jawaharlal Institute of Postgraduate Medical Education and Research","Puducherry","605006",{"type":57,"coordinates":130},[131,132],79.82979,11.93381,{"lat":132,"lon":131},[135,139,143,144,146],{"name":136,"role":41,"phone":137,"phoneExt":43,"email":138},"Prof. Dhanapathi H Halanaik, MD Nuclear Medicine","+91-9486398901","dhanapathih@gmail.com9486398901",{"name":140,"role":41,"phone":141,"phoneExt":43,"email":142},"Dr. Santha Kumar Senthilvelan, DM Interventional Radiology","+91-79442357488","santhakumar9001@gmail.com",{"name":136,"role":69,"phone":43,"phoneExt":43,"email":43},{"name":145,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Nandini Pandit, DNB Nuclear Medicine",{"name":140,"role":69,"phone":43,"phoneExt":43,"email":43},{"facility":103,"status":43,"city":148,"state":149,"zip":150,"country":54,"countryCode":55,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Delhi","South Delhi","110029",{"type":57,"coordinates":152},[153,154],77.23149,28.65195,{"lat":154,"lon":153},[157,161,165,167,168,170],{"name":158,"role":41,"phone":159,"phoneExt":43,"email":160},"Prof. Shamim Ahmad Shamim, MD Nuclear Medicine","+91-9868350491","sashamim2002@gmail.com",{"name":162,"role":41,"phone":163,"phoneExt":43,"email":164},"Prof. Shivanand Gamanagatti, MD Radiodiagnosis","+91-9868658057","shiv223@gmail.com",{"name":166,"role":37,"phone":43,"phoneExt":43,"email":43},"Prof. Shamim Ahmed Shamim, MD Nuclear Medicine",{"name":162,"role":69,"phone":43,"phoneExt":43,"email":43},{"name":169,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Maroof Ahmad Khan, Ph.D. Biostatistics",{"name":171,"role":69,"phone":43,"phoneExt":43,"email":43},"Prof. Shalimar, DM Gastroenterology",{"type":37,"investigatorFullName":173,"investigatorTitle":174,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Jaya Shukla","Professor",[176],{"name":177,"class":178},"Indian Council of Medical Research","OTHER_GOV","100626542","phase-1-affordable-made-in-india-microspheres-for-liver-cancer-therapy-100626542",false,"NCT07436988","Affordable Made-in-India Microspheres for Liver Cancer Therapy","Multicentric Study on Indigenous and Affordable Microspheres for Selective Internal Radiation Therapy (SIRT) of Unresectable Liver Cancer","ReLIVE","Inclusion Criteria:\n\n1. Age greater than or equal to 18 years (male or female)\n2. Histologically or radiologically confirmed diagnosis of HCC deemed inoperable\n3. Barcelona Clinic Liver Cancer stage B with ECOG performance status between 0 and 2\n4. At least one measurable lesion with longest diameter greater than or equal to 5 cm on cross sectional imaging\n5. Portal vein thrombosis may be present or absent\n6. Laboratory criteria:\n\n   1. Serum creatinine less than or equal to 1.5 mg per dL\n   2. Total bilirubin less than or equal to 2.0 mg per dL\n   3. AST or ALT less than or equal to 5 times upper limit of normal\n   4. Leukocyte count greater than or equal to 1500 per microliter\n   5. Platelet count greater than or equal to 50000 per microliter\n   6. Prothrombin time less than or equal to 1.3 times control or INR less than or equal to 1.5\n7. Karnofsky performance status greater than 70\n8. Ability and willingness to provide written informed consent for participation in the IEC approved protocol\n\nExclusion Criteria:\n\n1. Women of childbearing potential who are unwilling or unable to use effective contraception or who are pregnant or lactating\n2. Child Pugh class C liver function\n3. Presence of extrahepatic metastases\n4. Severe chronic pulmonary disease with hypoxemia or NYHA class three or four heart failure\n5. Myocardial infarction within the past six months\n6. Unstable arrhythmia or symptomatic cardiac disease\n7. Any other serious uncontrolled illness that in the investigator's opinion would compromise study participation\n8. History of other malignancy except adequately treated basal cell carcinoma or cervical carcinoma in situ within the last five years\n9. Major surgery within four weeks prior to enrolment\n10. Active uncontrolled bacterial infection requiring systemic therapy\n11. Liver rupture, tumor penetration of the liver capsule, tumor invasion of the biliary system, or biliary obstruction\n12. Known allergy or hypersensitivity to any component of the investigational or comparator microspheres\n13. Prior treatment with Selective Internal Radiation Therapy (SIRT)\n14. Estimated overall survival less than one month","ALL","18 Years","90 Years",{"count":191,"type":192},18,"ESTIMATED","INTERVENTIONAL",[195],"PHASE1","Primary liver tumors, with hepatocellular carcinoma (HCC) accounting for 80%, represent 6% of global cancer incidence and 9% of global cancer-associated mortality.HCC remains the leading causes of cancer-related deaths worldwide, due to late diagnosis. Although local-stage liver tumors are curable with tumor resection or livertransplantation, 65-70% of diagnosed cases are not suitable for resection due to large or multifocal lesions. For these patients, local therapies such as transcatheterarterial chemoembolization (TACE) or selective internal radiation therapy (SIRT) are appropriate at intermediate stages. In cases of advanced and metastatic livertumors, systemic therapies like sorafenib are the standard approach. Selective Intra-arterial Radionuclide Therapy (SIRT) offers a promising treatment for inoperableliver tumors by delivering beta-emitting radiolabeled microspheres directly to tumor sites through the liver's dual blood supply. However, the high cost of standard90Y-microspheres has limited accessibility for patients. This current project aims to develop, optimize, and validate the indigenously prepared microspheres forradiolabeling with 188Re from commercially available generator and indigenously produced radionuclide 177Lu (BARC Mumbai) for SIRT in liver cancer. With hightransformational impact, the current multicentric research will lead to a potentially safe, effective, and promising low-cost SIRT solution for low-income settings.Through collaboration across multiple centers, the study will evaluate the efficacy of microspheres labelled with both radionuclides. By establishing these accessibleSIRT options, this project strives to reduce financial barriers to treatment, advancing the goals of \"Jai Anusandhan\" towards building innovative therapeutics throughcollaborative research project and improving outcomes for patients with limited options.",[198],"Hepatecellular Carcinoma",[200,201,29,23,202,203,204,205],"SIRT","Hepatocellular Carcinoma","RADIANT","Targeted therapy","Liver Cancer","TARE","NOT_YET_RECRUITING","2026-03-11",{"date":209,"type":210},"2026-03-12","ACTUAL",{"date":212,"type":192},"2026-02-15",{"date":214,"type":192},"2028-10-15",{"name":5,"class":6},5]