[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462212":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":21,"locations":22,"responsibleParty":149,"collaborators":21,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":159,"sex":160,"minAge":161,"maxAge":21,"enrollmentInfo":162,"targetDuration":21,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":21,"overallStatus":25,"whyStopped":21,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Study arm","Imaging with CT-scan and MRI-DWI and peripheral blood samples for liquid biopsy",[12],"Diagnostic Test: Imaging analysis of CT-scan and MRI with radiomics and genetic analysis of peripheral blood samples and questionnaires.",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","Imaging analysis of CT-scan and MRI with radiomics and genetic analysis of peripheral blood samples and questionnaires.","* The images from CT scans and MRI with DWI will be processed using specialized software to determine the direction of diffusion tensors. This will indicate the diffusion direction using color coding (red, green, and blue for the x, y, and z components of the vector) and the intensity using anisotropy (brightness of voxels). Further analysis will be performed using fiber tracking, which provides a clear representation of the functional connectivity of adjacent tissues.\n* Genetic profiling of liquid biopsies: Multi-omics profiling of liquid biopsies (blood samples) will be conducted, followed by cell phenotyping, longitudinal analysis of driver mutations and epigenetic changes in cfDNA, and genotyping of germline variations.\n* Questionnaires for patient-reported outcomes and health economic analysis:\n\nEQ-5D-5L PAN 26 HADS",[9],[20],"Analysis of imaging with radiomics and genetic analysis of peripheral blood samples (liquid biopsy)",null,[23,52,66,80,90,100,114,130],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Ghent University Hospital","RECRUITING","Ghent","East Flanders","9000","Belgium","BE",{"type":32,"coordinates":33},"Point",[34,35],3.71667,51.05,{"lat":35,"lon":34},[38,43,47,49],{"name":39,"role":40,"phone":41,"phoneExt":21,"email":42},"Luis Filipe Abreu de Carvalho, MD","CONTACT","+32 9 332 5519","luis.abreudecarvalho@uzgent.be",{"name":44,"role":40,"phone":45,"phoneExt":21,"email":46},"betsy Van Loo, nurse","+32 9 332 4183","HBSurgeryStudy@uzgent.be",{"name":39,"role":48,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"name":50,"role":51,"phone":21,"phoneExt":21,"email":21},"Venita D'Cruz, MD","SUB_INVESTIGATOR",{"facility":53,"status":25,"city":54,"state":21,"zip":55,"country":29,"countryCode":30,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"AZ Sint Blasius Dendermonde","Dendermonde","9200",{"type":32,"coordinates":57},[58,59],4.10106,51.02869,{"lat":59,"lon":58},[62],{"name":63,"role":40,"phone":64,"phoneExt":21,"email":65},"Lars Triest, MD","+32 5 225 2011","Lars.Triest@azsintblasius.be",{"facility":67,"status":25,"city":68,"state":21,"zip":69,"country":29,"countryCode":30,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"AZ Alma Eeklo","Eeklo","9900",{"type":32,"coordinates":71},[72,73],3.55654,51.18703,{"lat":73,"lon":72},[76],{"name":77,"role":40,"phone":78,"phoneExt":21,"email":79},"Barbara Claerhout, MD","+32 9 310 0000","Barbara.Claerhout@azalma.be",{"facility":81,"status":25,"city":26,"state":21,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"AZ Jan Palfijn Ghent",{"type":32,"coordinates":83},[34,35],{"lat":35,"lon":34},[86],{"name":87,"role":40,"phone":88,"phoneExt":21,"email":89},"Steven Sas, MD","+32 9 224 7111","steven.sas@skynet.be",{"facility":91,"status":25,"city":26,"state":21,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"AZ Sint Lucs Ghent",{"type":32,"coordinates":93},[34,35],{"lat":35,"lon":34},[96],{"name":97,"role":40,"phone":98,"phoneExt":21,"email":99},"Johan Van Ongeval, MD","+32 9 224 6480","johan.vanongeval@azstlucas.be",{"facility":101,"status":25,"city":102,"state":21,"zip":103,"country":29,"countryCode":30,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"AZ Oudenaarde","Oudenaarde","9700",{"type":32,"coordinates":105},[106,107],3.60891,50.85168,{"lat":107,"lon":106},[110],{"name":111,"role":40,"phone":112,"phoneExt":21,"email":113},"Carolien Beyls, MD","+32 5 533 6111","Carolien.Beyls@azoudenaarde.be",{"facility":115,"status":25,"city":116,"state":21,"zip":117,"country":29,"countryCode":30,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"AZ Vitaz Sint Niklaas - Lokeren","Sint-Niklaas","9100",{"type":32,"coordinates":119},[120,121],4.1437,51.16509,{"lat":121,"lon":120},[124,128],{"name":125,"role":40,"phone":126,"phoneExt":21,"email":127},"Willem Lybaert, MD","+32 3 7606060","willem.lybaert@telenet.be",{"name":129,"role":51,"phone":21,"phoneExt":21,"email":21},"Koen Gorleer, MD",{"facility":131,"status":25,"city":132,"state":133,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"ZorgSaam ZH DeHonte Terneuzen","Terneuzen","Zeeland","4535 PA","Netherlands","NL",{"type":32,"coordinates":138},[139,140],3.82778,51.33583,{"lat":140,"lon":139},[143,147],{"name":144,"role":40,"phone":145,"phoneExt":21,"email":146},"Mark Sie, M.D. Ph.D. M.Sc.","+31 115 688 000","m.sie@zzv.nl",{"name":148,"role":51,"phone":21,"phoneExt":21,"email":21},"Marjan van Dijk, MD",{"type":150,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100462212","prediction-of-surgical-resectability-after-folfirinox-chemotherapy-for-borderline-resectable-and-locally-advanced-pancreatic-cancer-the-role-of-diffusion-weighted-magnetic-resonance-imaging-radiomics-and-liquid-biopsy-performance-trial-100462212",false,"NCT05298722","Prediction of Surgical Resectability After FOLFIRINOX Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: the Role of Diffusion Weighted Magnetic Resonance Imaging, Radiomics and Liquid Biopsy (PeRFormanCe Trial)","Prediction of Surgical Resectability After FOLFIRINOX Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: the Role of Diffusion Weighted Magnetic Resonance Imaging, Radiomics and Liquid Biopsy","PeRFormanCe","Inclusion Criteria:\n\n* Male or female patients, aged 18 years and above\n* Diagnosis of BR or LA PDAC according to NCCN guidelines (version 1.2020)\n* Histologic diagnosis of PDAC\n* No medical or anesthetic contra-indication for surgery\n* Able to understand nature of the study procedures\n* Willing to participate and give written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Distant metastases\n* Histologic diagnosis of cholangiocarcinoma, duodenal carcinoma or neuroendocrine tumor\n* Known hypersensitivity for MRI contrast\n* Pacemaker or prosthesis with incompatibility for MRI\n* Claustrophobia\n* Pregnancy or breastfeeding\n* Not able to understand nature of the study procedure\n* Performance status ECOG score: \\>2",true,"ALL","18 Years",{"count":163,"type":164},45,"ESTIMATED","INTERVENTIONAL",[167],"NA","In this prospective study, new diagnostic tools will be explored for patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (BR or LAPDA) who undergo neoadjuvant chemotherapy with FOLFIRINOX. The diagnostic work-up and therapy for the study population will not differ from the gold standard during the study; only additional diagnostic tools will be implemented, and their value will be analyzed post hoc.\n\nThe 5-year survival rate of pancreatic cancer is 9%, but this can be drastically improved if surgery is possible. With its increasing incidence and poor prognosis, pancreatic cancer is becoming a global oncologic challenge where major breakthroughs are still required to improve patient outcomes. Patients with BR or LAPDA typically undergo neoadjuvant treatment with FOLFIRINOX chemotherapy, followed by referral for surgery if a response is observed. In these cases, surgical resectability is difficult to predict based on CT imaging due to the tumor's desmoplastic reaction, which obscures tumor-vessel contact without clear morphological changes. Consequently, patients without tumor progression on CT and with a decreased tumor marker (CA 19-9) are considered for surgical exploration to ensure that no potentially curative treatment is denied. However, the non-specific nature of CA 19-9 and the unreliable spatial changes on CT do not allow for accurate patient stratification. Therefore, alternative diagnostic strategies are needed to better predict resectability, minimizing unnecessary laparotomies while ensuring that potentially curative approaches are not overlooked.\n\nIn this project, the investigator will apply diffusion-weighted magnetic resonance imaging (DW-MRI), as it has been shown to be useful in assessing tumor response beyond morphological parameters. DW-MRI enables the detection of functional tumor changes, variations in vascularization, and fibrosis without modifications in shape. The statistical evaluation of visual information using radiomics optimizes data analysis, allowing comparisons over time (before and after chemotherapy) and correlation with operative findings (resectable or unresectable tumor).\n\nThe investigator will focus on patients with BR and LAPDA and assess whether a combination of clinical and genetic factors can predict successful surgical resection. To this end, DW-MRI imaging will be complemented by multi-omics profiling in liquid biopsies. Furthermore, the investigator aims to validate, in a prospective patient cohort, the predictive value of recently published single nucleotide polymorphisms (SNPs) in genes that regulate cancer progression, invasion, and metastasis. Some alleles of these SNPs have been associated with an increased risk of tumor-related mortality compared to protective genotypes.",[170],"Pancreatic Cancer","2025-03-28",{"date":173,"type":174},"2025-04-02","ACTUAL",{"date":176,"type":174},"2022-12-12",{"date":178,"type":164},"2028-03",{"name":5,"class":6},8]