[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06173310":3,"trial-entities:NCT06173310":104,"trial-summary:NCT06173310":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":53,"locations":56,"central_contacts":97,"overall_officials":100,"references":102,"see_also_links":103},"NCT06173310","300012110","DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer","RECRUITING","2029-03","2025-02","2026-02-27","2024-10-10","Ohio State University","OTHER",false,"The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.",null,[18],"Borderline-resectable Pancreatic Cancer",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Point-of-care Portable Perfusion Phantom (P4)","P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.",[33],"borderline-resectable pancreatic cancer (BRPC)",[35],{"measure":36,"description":37,"timeFrame":38},"To measure the reproducibility of qDCE-MRI measurement of BRPC.","The pharmacokinetic (PK) parameter within the region of interest (ROI) will be averaged at each scan after P4-based error correction, and the mean values of two scans will be compared to calculate the reproducibility coefficient (%RDC) using the equation, %RDC=2.77wCV, where wCV is the within-subject coefficient of variation. The %RDC before P4-based error correction will also be calculated for comparison. Data reproducibility will be assessed using the intra-class correlation coefficient (ICC) as well. ICC = σ 2b \u002F (σ 2b+ σ 2w), where σb is between-subject standard deviation and σw is within-subject standard deviation.","6 weeks +\u002F- 2 weeks",[],"ALL","19 Years",{"inclusion":43,"exclusion":47,"raw_text":52},[44,45,46],"Adult patients (age 19 years or older).","Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.","Patients with signed informed consent.",[48,49,50,51],"Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer.","Participants with safety contraindications to MRI examination (determined by standard clinical screening).","Participants who are pregnant, lactating or are planning to become pregnant during the study.","Participants who are planning to father a child during the study.","Inclusion Criteria:\n\n* Adult patients (age 19 years or older).\n* Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.\n* Patients with signed informed consent.\n\nExclusion Criteria:\n\n* Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer.\n* Participants with safety contraindications to MRI examination (determined by standard clinical screening).\n* Participants who are pregnant, lactating or are planning to become pregnant during the study.\n* Participants who are planning to father a child during the study.",[54,55],"ADULT","OLDER_ADULT",[57,82],{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":79},"Indiana University Medical Center","Indianapolis","Indiana","46202","United States",[64,69,72,75,77],{"name":65,"role":66,"phone":67,"email":68},"D D","CONTACT","5555555555","D@UAB.EDU",{"name":70,"role":71},"Asiq Masood, MD","PRINCIPAL_INVESTIGATOR",{"name":73,"role":74},"Jordan Swensson, MD","SUB_INVESTIGATOR",{"name":76,"role":74},"Yu-Chien Wu, MD",{"name":78,"role":74},"Omer Saeed, MD",{"lat":80,"lon":81},39.76838,-86.15804,{"facility":83,"status":7,"city":84,"state":85,"zip":86,"country":62,"contacts":87,"geoPoint":94},"The Ohio State University","Columbus","Ohio","43210",[88,92],{"name":89,"role":66,"phone":90,"email":91},"Tamara Stein, MPH","614-293-8315","Tamara.Steinm@osumc.edu",{"name":93,"role":71},"Harrison Kim, PhD",{"lat":95,"lon":96},39.96118,-82.99879,[98],{"name":89,"role":66,"phone":90,"email":99},"Tamara.Stein@osumc.edu",[101],{"name":93,"affiliation":12,"role":71},[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Pancreatic Carcinoma",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This interventional study plans to enroll 50 adult participants with borderline resectable pancreatic cancer.","completed","DCE-MRI Guided Chemotherapy for Borderline Resectable Pancreatic Cancer","This study is testing if chemotherapy guided by a special imaging method called Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) can better shrink pancreatic tumors that are \"borderline resectable.\" This means the tumor is currently difficult to remove with surgery but might become removable after treatment. Researchers at UAB have been studying DCE-MRI for over 10 years; it measures blood flow in tissues, which can indicate a tumor's status. The goal is to see if using DCE-MRI to guide chemotherapy can make surgery possible for more patients. You may be able to join if you are an adult (19 or older) with newly diagnosed, untreated borderline resectable pancreatic cancer. The study is enrolling 50 participants, but its current recruitment status is unclear. Success for this study means showing that DCE-MRI measurements of these tumors are reliable and consistent.","The primary endpoint is measured at 6 weeks (+\u002F- 2 weeks).",137,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]