[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597409":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":32,"enrollmentInfo":69,"targetDuration":32,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Neutron Therapeutics, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single group - Dose escalation study","EXPERIMENTAL","Two BNCT trial treatments are scheduled to be administered to each study subject with a 4-week time interval between the 2 trial treatments (a range from 3.0 to 6.0 weeks is allowed for the interval). Neutron irradiations are given at the Helsinki University Hospital BNCT facility (Helsinki, Finland) using the nuBeam Suite. The nuBeam Treatment Delivery System within the nuBeam Suite delivers a neutron beam that has suitable energy and flux for clinical BNCT.\n\nThe Instructions for Use\u002FUser Guide(s) containing the detailed instructions for using the system will be followed for the delivery of neutron irradiation for each BNCT trial treatment.\n\nThe basic steps for the irradiation procedure are:\n\n1. Neutron source preparation\u002Fcalibration\n2. CT imaging of the target region\n3. Positioning of the study subject\n4. Irradiation to the planned trial treatment dose\n5. Close-out\u002FShutdown Each BNCT trial treatment will be carried out according to the trial treatment plan.",[13],"Drug: L-Boronophenylalanine intravenous administration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","L-Boronophenylalanine intravenous administration","L-BPA will be complexed with fructose to form L-BPA-fructose (L-BPA-F) to increase solubility, and 400 mg\u002Fkg of L-BFA as complexed with fructose (L-BPA-F) will then be administered intravenously at a concentration of L-BPA 30 g\u002FL over 2 hours before neutron irradiation.",[9],[21],"Neutron Irradiation",[23],{"name":24,"affiliation":25,"role":26},"Angel Estrada, PhD","Neutron Therapeutics","STUDY_CHAIR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Anu Anttonen, MD, PhD","CONTACT","358 50 4279911",null,"anu.anttonen@hus.fi",[35],{"facility":36,"status":37,"city":38,"state":32,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Helsinki University Hospital","RECRUITING","Helsinki","00290","Finland","FI",{"type":43,"coordinates":44},"Point",[45,46],24.93545,60.16952,{"lat":46,"lon":45},[49,51],{"name":50,"role":30,"phone":31,"phoneExt":32,"email":33},"Anu Anttonen, MD PhD",{"name":50,"role":52,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[56],{"name":57,"class":58},"Helsinki University Central Hospital","OTHER","100597409","phase-1-accelerator-based-bnct-boron-neutron-capture-therapy-for-head-and-neck-carcinoma-100597409",false,"NCT07058116","Accelerator-based BNCT (Boron Neutron Capture Therapy) for Head and Neck Carcinoma.","Accelerator-based Boron Neutron Capture Therapy (BNCT) in the Treatment of Locally Recurrent Head and Neck Carcinoma: A Phase I Study.","BNCT","Inclusion Criteria:\n\n1. The patient considered for the study has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.\n2. ≥ 18 years of age at the time of enrollment.\n3. Histologically confirmed head and neck carcinoma.\n4. Inoperable cancer, prior surgery may or may not have been done.\n5. Prior radiotherapy or chemoradiotherapy has been given.\n6. Anticipated life expectancy of at least 6 months.\n\nExclusion Criteria:\n\nPatients who fulfill any of the following criteria will be excluded:\n\n1. Presence of distant metastases.\n2. World Health Organization (WHO) performance status \\> 2 (see Appendix 2).\n3. Concurrent uncontrolled localized cancer other than head and neck carcinoma or overtly metastatic cancer.\n4. The patient has access to a non-experimental, effective treatment option and is a suitable candidate for such therapy.\n5. Concomitant chemotherapy.\n6. Concurrent experimental therapy or participation in a trial with an experimental therapy within 3 months prior to study inclusion.\n7. Less than 3 months since prior radiation therapy.\n8. Major surgery within 4 weeks prior to study inclusion.\n9. Unremovable metal implants present in the head and neck region that will interfere with CT\u002FMRI-based dose-planning.\n10. Known sensitivity to the study drug.\n11. One or more of the following:\n\n    * Blood hemoglobin \\\u003C 100 g\u002FL, neutrophils \\\u003C 1.5 x 109\u002FL, platelet count \\\u003C 120 x 109\u002FL\n    * Serum\u002Fplasma creatinine \\> 1.5 x Upper Limit of Normal (ULN)\n    * Serum bilirubin 2.0 \\> ULN\n    * Serum ALT and\u002For AST \\> 2.0 x ULN\n    * Serum alkaline phosphatase \\> 2.5 x ULN\n12. Serious uncontrolled infection or other serious uncontrolled concomitant disease.\n13. Collagen vascular disease or a disease that is considered to increase radiosensitivity of normal tissues to radiation (e.g., ataxia-telangiectasia)\n14. The patient is unwilling or unable to comply with the CIP required follow-up visits for the duration of the study.\n15. Untreated or severe treated congestive heart failure, cardiac pacemaker, or renal failure.\n16. Restlessness or inability to lie in a cast for about 30 minutes.\n17. Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in the follow-up.\n18. Known pregnancy, breastfeeding, or planning of pregnancy; for women of childbearing potential, a negative urine pregnancy test must be obtained prior to enrollment.\n19. The patient is not able to understand the nature of the study and trial treatment options.\n20. Phenylketonuria.\n21. Fructose intolerance.","ALL","18 Years",{"count":70,"type":71},10,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This phase I study of an accelerator-based boron neutron capture therapy (BNCT) in the treatment of locally recurrent head and neck carcinoma, is sponsored by HUS, Haartmaninkatu 4, Helsinki, Finland and Neutron Therapeutics Finland OY, Kanavaranta 9 FIN-00290 Helsinki.\n\nThe indication is for patients with head and neck carcinoma that has recurred locally after conventional radiation therapy.\n\nThe primary objective is to demonstrate the safety of accelerator-based neutron radiation using the nuBeam Suite in delivering BNCT.\n\nThe secondary objective is the ability to deliver the planned radiation dose to the target site and the ability to plan the trial treatment using the trial treatment planning software, position and target the tumor site using the robotic table in conjunction with the CT scanner and calculate the required radiation dose for each planned BNCT trial treatment.\n\nTo establish these objectives, the following parameters will be controlled:\n\n* Objective response rate\n* Duration of response.\n* The clinical benefit rate (includes complete response, partial response, and stabilized disease for a minimum of 8 weeks since the date of the first BNCT).\n* Locoregional recurrence-free survival.\n* Progression-free survival.\n* Overall survival.\n* Quality of life.\n\nThe maximum sample size is 10 study subjects evaluable for safety.\n\nThe study does not involve randomization.\n\nRegarding the target population, the study subjects must fulfill each of the inclusion criteria:\n\n1. Patient has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.\n2. ≥ 18 years of age at the time of enrollment.\n3. Histologically confirmed head and neck carcinoma.\n4. Inoperable cancer, prior surgery may or may not have been done.\n5. Prior radiotherapy or chemoradiotherapy has been given.\n6. Anticipated life expectancy of at least 6 months\n\nPatients who fulfill any of the following criteria will be excluded:\n\n1. Presence of distant metastases.\n2. World Health Organization (WHO) performance status \\> 2\n3. Concurrent uncontrolled localized cancer other than head and neck carcinoma or overtly metastatic cancer.\n4. The patient has access to a non-experimental, effective treatment option and is a suitable candidate for such therapy.\n5. Concomitant chemotherapy.\n6. Concurrent experimental therapy or participation in a trial with an experimental therapy within 3 months prior to study inclusion.\n7. Less than 3 months since prior radiation therapy.\n8. Major surgery within 4 weeks prior to study inclusion.\n9. Unremovable metal implants present in the head and neck region that will interfere with CT\u002FMRI-based dose-planning.\n10. Known sensitivity to the study drug.\n11. One or more of the following:\n\n    * Blood hemoglobin \\\u003C 100 g\u002FL, neutrophils \\\u003C 1.5 x 109\u002FL, platelet count \\\u003C 120 x 109\u002FL\n    * Serum\u002Fplasma creatinine \\> 1.5 x Upper Limit of Normal (ULN)\n    * Serum bilirubin 2.0 \\> ULN\n    * Serum ALT and\u002For AST \\> 2.0 x ULN\n    * Serum alkaline phosphatase \\> 2.5 x ULN\n12. Serious uncontrolled infection or other serious uncontrolled concomitant disease.\n13. Collagen vascular disease or a disease that is considered to increase radiosensitivity of normal tissues to radiation (e.g., ataxia-telangiectasia)\n14. Patient is unwilling or unable to comply with the CIP required follow-up visits for the duration of the study.\n15. Untreated or severe treated congestive heart failure, cardiac pacemaker, or renal failure.\n16. Restlessness or inability to lie in a cast for about 30 minutes.\n17. Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in the follow-up.\n18. Known pregnancy, breastfeeding, or planning of pregnancy; for women of childbearing potential, a negative pregnancy test must be obtained prior to enrollment.\n19. The patient is not able to understand the nature of the study and trial treatment options.\n20. Phenylketonuria\n21. Fructose intolerance.\n\nThere is one investigational device included as part of this study. The nuBeam Suite has two main components, the Treatment Delivery System and the nuBeam Dose Engine.\n\nThe study drug included in this study is L-boronophenylalanine fructose (L-BPA Fructose)",[77],"Head and Neck Carcinoma",[79,65,80,77,25,36],"L-Boronophenylalanine","Boron Neutron Capture Therapy","2025-07-04",{"date":83,"type":84},"2025-07-10","ACTUAL",{"date":86,"type":84},"2025-05-08",{"date":88,"type":71},"2026-01-30",{"name":5,"class":6},1]