[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463617":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":88,"collaborators":25,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":25,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":25,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"V-SBRT","EXPERIMENTAL","Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)",[13],"Procedure: Vertebroplasty",{"label":15,"type":6,"description":16,"interventionNames":17},"SBRT","SBRT is the actual standard of care.",[18],"Procedure: Stereotactic Body Radiation Therapy only",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Vertebroplasty","SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume.\n\nThe vertebroplasty will be performed according to the usual procedure at the center in the angiography suite under local anesthesia and conscious sedation\n\n* Introduction of a vertebral needle, under biplanar fluoroscopic guidance, polymethylmethacrylate (PMMA) cement injection.\n* Cone-beam volume-CT at the end of the procedure, with the angiography table and c-arm, to evaluate the cement distribution and detect any leak.\n* Decubitus position for 2 hours following procedure, then hospital discharge on the same day.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Stereotactic Body Radiation Therapy only","SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume",[15],[15],[32],{"name":33,"affiliation":5,"role":34},"Véronique Freire, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","514-890-8000","veronique.freire.med@ssss.gouv.qc.ca",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Fidaa Al-Shakfa, M.sc.","f.alshakfa.crchum@gmail.com",[44,66],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"CHUM","RECRUITING","Montreal","Quebec","H2X0C1","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-73.58781,45.50884,{"lat":56,"lon":55},[59,62],{"name":60,"role":37,"phone":61,"phoneExt":25,"email":39},"Veronique Freire, MD","514-883-6154",{"name":63,"role":37,"phone":64,"phoneExt":65,"email":25},"Mom PHAT","514 890-8000","11171",{"facility":67,"status":46,"city":47,"state":48,"zip":25,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Véronique Freire",{"type":53,"coordinates":69},[55,56],{"lat":56,"lon":55},[72,73,76,78,80,82,84,86],{"name":33,"role":37,"phone":25,"phoneExt":25,"email":25},{"name":74,"role":75,"phone":25,"phoneExt":25,"email":25},"Laura Masucci, MD","SUB_INVESTIGATOR",{"name":77,"role":75,"phone":25,"phoneExt":25,"email":25},"David Donath, MD",{"name":79,"role":75,"phone":25,"phoneExt":25,"email":25},"David Roberge, MD",{"name":81,"role":75,"phone":25,"phoneExt":25,"email":25},"Taussky Daniel, MD",{"name":83,"role":75,"phone":25,"phoneExt":25,"email":25},"Shedid Daniel, MD",{"name":85,"role":75,"phone":25,"phoneExt":25,"email":25},"Sung-Joo Yuh, MD",{"name":87,"role":75,"phone":25,"phoneExt":25,"email":25},"Zhi Wang, MD",{"type":89,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100463617","increased-early-pain-relief-by-adding-vertebroplasty-to-sbrt-100463617",false,"NCT05317026","Increased Early Pain Relief by Adding Vertebroplasty to SBRT","Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief","Inclusion Criteria:\n\n* Histological evidence of cancer.\n* Spinal and vertebral bone metastases (T5 to L5) documented by imaging.\n* Pain related to metastases ≥ 4 on a numerical scale 0-10.\n* Karnofsky performance index \\> 60 (ecog 0-2)\n* Candidate for SBRT\n* Less than 3 consecutive levels reached.\n* Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment.\n* Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (\\> or = 7)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Contraindications to MRI.\n* Histology: myeloma, lymphoma or plasmacytoma.\n* Radiotherapy prior to the level to be treated.\n* Previous surgery at the site to be treated.\n* Surgical indication:\n\nspinal instability neoplastic score (SINS) \\> 13 or according to tumor board consensus.\n\nBilsky score \\> or = 2 Severe or progressive neurological signs (motor, incontinence).\n\n* Lesion too large for safe vertebroplasty.\n* High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above).\n* Non-reversible coagulation disorders.\n* Uncontrolled local or systemic infection.\n* Estimated survival of less than 6 months.\n* Inability or refusal to undergo SBRT treatment or vertebroplasty","ALL","18 Years",{"count":100,"type":101},50,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.",[107,108,109],"Spine Metastases","Radiation Therapy","Pain","2024-08-06",{"date":112,"type":113},"2024-08-07","ACTUAL",{"date":115,"type":113},"2023-11-22",{"date":117,"type":101},"2027-12-31",{"name":5,"class":6},2]