[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06965166":3,"trial-entities:NCT06965166":98,"trial-summary:NCT06965166":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":15,"eligibility_criteria":45,"std_ages":62,"locations":65,"central_contacts":88,"overall_officials":91,"references":93,"see_also_links":94},"NCT06965166","24-001797","Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer","Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer","RECRUITING","2026-12-31","2026-04","2026-04-22","2024-10-07","Mayo Clinic","OTHER",false,"This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.",null,[19],"Rectal Carcinoma",[],"OBSERVATIONAL",[],{"count":24,"type":25},200,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"PROCEDURE","PCD-CT","Participants undergo PCD-CT scan on study",[32],"Observational",[34,35],"contrast-enhanced photon-counting detector CT","contrast-enhanced photon-counting detector computed tomography",[37],{"measure":38,"description":39,"timeFrame":40},"Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement","Images from contrast-enhanced pelvic PCD-CT for circumferential resection margin (CRM) involvement will be compared to rectal cancer MRI images. A single-group design will be used to test whether the proportion is non-inferior, with a noninferiority difference (P0 - PB) of -0.1 (H0: P ≤ P0 versus H1: P \\> P0). The comparison will be made using a one-sided, one-sample exact binomial test, with a Type I error rate (alpha) of 0.05. The limit of non-inferiority will be set at -0.10, meaning that the lower limit of the estimate of the difference between the modalities will be greater than -0.10 for PCD-CT to be non-inferior.","Baseline (after research CT scan has been performed)",[],"ALL","18 Years","99 Years",{"inclusion":46,"exclusion":52,"raw_text":61},[47,48,49,50,51],"Adult patients 18 to 99 years of age","Patients with proven rectal cancer clinically referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis (for evaluation of liver and peritoneal disease)","Endoscopic or imaging report that tumor is 2 cm or larger","Patients who are able and willing to sign the informed consent","Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient)",[53,54,55,56,57,58,59,60],"Minors less than 18 years old","Patient unable to provide written informed consent","Pregnancy","Estimated Glomerular Filtration Rate (eGFR) ≤ 60","History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis","Any history of premedication prior to iodinated contrast","Bilateral hip replacement\u002Fprosthesis","Patients that consent to participation but do not undergo their clinically indicated MRI scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication)","Inclusion Criteria:\n\n* Adult patients 18 to 99 years of age\n* Patients with proven rectal cancer clinically referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis (for evaluation of liver and peritoneal disease)\n* Endoscopic or imaging report that tumor is 2 cm or larger\n* Patients who are able and willing to sign the informed consent\n* Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient)\n\nExclusion Criteria:\n\n* Minors less than 18 years old\n* Patient unable to provide written informed consent\n* Pregnancy\n* Estimated Glomerular Filtration Rate (eGFR) ≤ 60\n* History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis\n* Any history of premedication prior to iodinated contrast\n* Bilateral hip replacement\u002Fprosthesis\n* Patients that consent to participation but do not undergo their clinically indicated MRI scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication)",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":85},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[73,78,82],{"name":74,"role":75,"phone":76,"email":77},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":79,"role":75,"phone":80,"email":81},"Boleyn Andrist","507-538-7752","andrist.boleyn@mayo.edu",{"name":83,"role":84},"Joel G. Fletcher, MD","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},44.02163,-92.4699,[89,90],{"name":74,"role":75,"phone":76,"email":77},{"name":79,"role":75,"phone":80,"email":81},[92],{"name":83,"affiliation":67,"role":84},[],[95],{"label":96,"url":97},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":99,"biomarkers":100},[19],[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study with a planned enrollment of 200 participants. It is not specified if it is randomized or blinded.","completed","Observational Study of PCD-CT for Rectal Cancer Staging","This study is looking at whether a special type of CT scan, called a photon-counting detector CT (PCD-CT), can be as good as or better than an MRI for checking how much rectal cancer has grown. Researchers want to see if PCD-CT can accurately show if the cancer has spread to the circumferential resection margin (CRM), which is important for treatment planning. You might be able to join if you are an adult between 18 and 99 years old with confirmed rectal cancer that is 2 cm or larger, and you are already scheduled for a pelvic MRI and a contrast-enhanced CT scan. The study aims to enroll 200 participants. The current recruitment status is unclear.","The primary endpoint is measured at Baseline, after the research CT scan has been performed. No further follow-up is specified.",116,"Participants will undergo a PCD-CT scan as part of the study. The record does not specify additional visits or procedures.","Not stated in the trial record.",[29],"v2"]