[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608493":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"University of Utah","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Simulation-free, single-fraction palliative radiation therapy","EXPERIMENTAL",null,[13],"Radiation: simulation-free, single-fraction palliative radiation therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"RADIATION","simulation-free, single-fraction palliative radiation therapy","Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Rachel Kingford","CONTACT","8015850115","Rachel.kingsford@hci.utah.edu",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Shane Lloyd, MD","8015850255","Shane.lloyd@hci.utah.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Huntsman Cancer Institute\u002FUniversity of Utah","RECRUITING","Salt Lake City","Utah","84112","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-111.89105,40.76078,{"lat":43,"lon":42},[46,49],{"name":47,"role":23,"phone":48,"phoneExt":11,"email":25},"Rachel Kingsford","801-585-0115",{"name":27,"role":23,"phone":50,"phoneExt":11,"email":29},"801-585-0255",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100608493","simulation-free-single-fraction-palliative-radiation-therapy-for-treatment-of-bone-metastases-100608493",false,"NCT07202273","Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases","A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)","SIM-FREE RT","Inclusion Criteria:\n\n* Participant aged ≥ 18 years.\n* Diagnosis of any cancer with one to two painful and treatable metastatic bone lesions.\n* Bone metastases are causing pain or instability in the opinion of the treating investigator.\n* Amenable to single fraction radiation therapy per the discretion of the treating physician.\n* CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.\n* ECOG Performance Status ≤ 2.\n* Participants must adhere to the following sex and contraceptive\u002Fbarrier requirements:\n\n  * If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy test are available for review before treatment.\n  * For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n    * \\\u003C 50 years of age:\n\n      * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n      * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n\n        ---≥ 50 years of age:\n      * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n      * Had radiation-induced menopause with last menses \\>1 year ago; or\n      * Had chemotherapy-induced menopause with last menses \\>1 year ago\n    * Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Evidence of spinal cord compression caused by the bone metastases to be treated.\n* Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Participants taking prohibited medications as described in Section 6.7.1.","ALL","18 Years",{"count":64,"type":65},40,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.",[71],"Bone Metastases","2025-11-03",{"date":74,"type":75},"2025-11-05","ACTUAL",{"date":72,"type":75},{"date":78,"type":65},"2028-10",{"name":5,"class":6},1]