[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533322":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":47,"studyPopulation":48,"armGroups":49,"interventions":57,"overallOfficials":71,"centralContacts":76,"locations":86,"responsibleParty":105,"collaborators":43,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":43,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":120,"studyType":121,"phases":43,"briefSummary":122,"conditions":123,"keywords":43,"overallStatus":88,"whyStopped":43,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"British Columbia Cancer Agency","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":43},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"To determine the tolerability of [18F]BL40","Occurrence of dose-limiting toxicities (DLTs) per protocol.","1 hour post injection, 2 hours post injection and 18-72 hours post injection",{"measure":14,"description":15,"timeFrame":16},"To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40","Absorbed doses (ADs) to organs and tumors per unit of administered activity is measured in units Gy\u002FMBq.\n\n(Tumor, individual organ dose and whole-body effective dose)","6 months",{"measure":18,"description":19,"timeFrame":20},"To evaluate the proportion of participants with tumors shown by [18F]BL40 PET\u002FCT","Proportion of patients with \\[18F\\]BL40 positive disease at core reading.","1 year",{"measure":22,"description":23,"timeFrame":16},"To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40","Average time the activity spends in the organ or tumor, measured in units MBq·h\u002FMBq",{"measure":25,"description":26,"timeFrame":12},"To determine the safety of [18F]BL40","Proportion of subjects with adverse events (AEs), Grade 3 or above AEs, drug-related AEs",[28,31,34,37,40],{"measure":29,"description":30,"timeFrame":20},"The proportion of patients in whom [18F]BL40 and [18F]FDG detect disease","The proportion of patients in whom one or more target lesions are detected by the core readers",{"measure":32,"description":33,"timeFrame":20},"To compare the number of lesions identified in [18F]BL40 and [18F]FDG","Scan features for comparison may include, but are not limited to:\n\nTotal number of lesions detected",{"measure":35,"description":36,"timeFrame":20},"To assess tumour detectability and image quality by means of standardised uptake values (SUV) for tumour lesions in [18F]BL40 compared to 2[18F]FDG PET\u002FCT (SUVmax, SUVpeak, tumour to background ratio for liver, blood, and lung, contrast to noise ratio)","Standard Uptake Values (SUV)\n\nmean SUV\n\nmaximum SUV\n\npeak SUV\n\nTumor tissue to Background tissue ratio, Tumor\u002Fblood; Tumor\u002FLiver; Tumor\u002F kidney",{"measure":38,"description":39,"timeFrame":20},"To compare the lesions identified in [18F]BL40 and [18F]FDG","Scan features for comparison may include, but are not limited to:\n\nSite of lesions",{"measure":41,"description":42,"timeFrame":20},"To assess reader confidence","Diagnostic confidence on a three-point scale (high, moderate and low)",null,{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":45,"timePerspective":46,"maskingInfo":43},"COHORT","PROSPECTIVE","This is a prospective registry study to evaluate the diagnostic utility of 18F-BL40 PET\u002FCT to stage patients with CXCR4-expressing tumors, localize sites of tumors and assess safety and biodistribution of this drug in PET\u002FCT scans.\n\nEach subject will receive two PET\u002FCT scans, one using 18F-BL40 and the other using 18F-FDG. The 18F-BL40 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.\n\nFollow-up assessments: All subjects will be contacted by phone the day after the injection of 18F-BL40. The subjects will be asked if they experienced any undesirable effects during the 18-72 hours after the administration of 18F-BL40. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 18F-BL40 administration.\n\nAll subjects will be followed for at least 6 months following the 18F-BL40 PET\u002FCT exam. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.","This will be a prospective, open-label trial in patients with newly diagnosed or documented recurrent malignancy with one of the following cancers:\n\n* Diffuse large B-Cell lymphoma\n* Multiple myeloma\n* Mantle cell lymphoma\n* Marginal zone lymphoma\n* Chronic lymphocytic leukemia\u002Fsmall cell lymphoma\n* Waldenström Macroglobulinemia",[50],{"label":51,"type":43,"description":52,"interventionNames":53},"18F-BL40 PET\u002FCT scan","Each subject will have two PET\u002FCT scans, one using 18F-BL40 and the other using 18F-FDG. The 18F-BL40 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.",[54,55,56],"Diagnostic Test: 18F-BL40 PET\u002FCT","Diagnostic Test: 18F-FDG PET\u002FCT","Diagnostic Test: Routine Blood Draw - Phase 1 only",[58,63,67],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":43},"DIAGNOSTIC_TEST","18F-BL40 PET\u002FCT","Phase 1 (Patients 1-10):\n\nVital signs will be recorded prior to the BL40 injection. Each study subject will have an intravenous catheter inserted. Prior to the radiotracer injection an ultra low dose CT will be taken. The subject will receive a bolus intravenous dose of the 18F-BL40. A Dynamic PET scan will be taken of the heart followed by serial whole body PET scan will be done. Vital signs will be taken again and the subject will have a bathroom break. The patient will return to the scanner bed for a standard low dose CT and whole body PET scan. Vital signs will be taken again, and subject will be allowed to use the washroom again. The subject will return to the scanner bed for the final time for an ultra low dose CT and whole body PET scan. A final set of vitals will be taken and the subject will be discharged.\n\nPhase 2 (11-30):\n\nIV bolus dose of BL40, 1 hours uptake time followed by 15-minute static scan. No vital signs taken.",[51],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":43},"18F-FDG PET\u002FCT","The patient will return on another day for the 18F-FDG PET\u002FCT scan. A fasting period of 6 hours is required before this scan.\n\nEach study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.\n\nThe subject will rest in a comfortable chair for 60 minutes. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.\n\nSubjects are positioned supine, arms down, and centered on the scanner bed and the PET\u002FCT images will be acquired.",[51],{"type":59,"name":68,"description":69,"armGroupLabels":70,"otherNames":43},"Routine Blood Draw - Phase 1 only","Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.",[51],[72],{"name":73,"affiliation":74,"role":75},"Ian Alberts","BC Cancer","PRINCIPAL_INVESTIGATOR",[77,83],{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},"Pav Ravi","CONTACT","6048776000","2818","pavithraa.ravi@bccancer.bc.ca",{"name":84,"role":79,"phone":80,"phoneExt":81,"email":85},"Heather Saprunoff","hsaprunoff@bccancer.bc.ca",[87],{"facility":74,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"RECRUITING","Vancouver","British Columbia","V5Z4E6","Canada","CA",{"type":95,"coordinates":96},"Point",[97,98],-123.11934,49.24966,{"lat":98,"lon":97},[101,103,104],{"name":102,"role":79,"phone":80,"phoneExt":81,"email":82},"Pavithraa Ravi",{"name":84,"role":79,"phone":80,"phoneExt":81,"email":85},{"name":73,"role":75,"phone":43,"phoneExt":43,"email":43},{"type":106,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100533322","preliminary-assessment-of-18fbl40-in-petct-scans-100533322",false,"NCT06224309","Preliminary Assessment of [18F]BL40 in PET\u002FCT Scans","A Phase 2 Study to Evaluate the in Vivo Biodistribution, Radiation Dosimetry and a Preliminary Assessment of the Diagnostic Performance of [18F]BL40","Inclusion Criteria:\n\n1. Age ≥19 years\n2. Life expectancy ≥3 months\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n4. Participants with newly diagnosed or documented recurrent malignancy with one of the following cancers:\n\n   * Diffuse large B-Cell lymphoma\n   * Multiple myeloma\n   * Mantle cell lymphoma\n   * Marginal zone lymphoma\n   * Chronic lymphocytic leukemia\u002Fsmall cell lymphoma\n   * Waldenström Macroglobulinemia\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding\n2. Medically unstable (e.g., acute illness, unstable vital signs)\n3. Unable to lie supine for the duration of imaging\n4. Unable to provide written consent\n5. Exceeds safe weight limit of the PET\u002FCT bed (204.5 kg) or unable to fit through the PET\u002FCT bore (diameter 70 cm)\n6. Participants with a history of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to the peptide diagnostic \\[18F\\]BL40 or any of its excipients.","ALL","19 Years","100 Years",{"count":118,"type":119},30,"ESTIMATED","6 Months","OBSERVATIONAL","CXCR4 is type of receptor that has been detected in more than twenty different subtypes of cancers. Most of these cancers are associated with negative symptoms that worsen over time resulting in great disability and poor function. There is a need for novel tracers to image CXCR4-expressing tumors for better detection, staging, and monitoring of aggressive cancers without the need for invasive biopsy procedures that may not always properly capture the extent of a patient's disease.\n\nThis study looks to assess the safety and efficacy of a novel radiopharmaceutical known as 18F-BL40 through its use in a PET\u002FCT scan. Participants will receive 2 PET\u002FCT scans:\n\n18F-BL40 and 18F-FDG as part of this study.",[124,125,126,127,128,129],"Diffuse Large B-cell Lymphoma","Multiple Myeloma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Chronic Lymphocytic Leukemia","Waldenström Macroglobulinemia","2026-09-28",{"date":132,"type":133},"2026-10-01","ACTUAL",{"date":135,"type":133},"2024-06-10",{"date":137,"type":119},"2027-09-15",{"name":5,"class":6},1]