[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586159":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":36,"locations":44,"responsibleParty":59,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Friedrich-Alexander-Universität Erlangen-Nürnberg","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","The control group consists of young, healthy adults without bowel emptying disorders. The aim of this group is to provide baseline measurements for gastrointestinal transit time and peristalsis using Multispectral Optoacoustic Tomography (MSOT) and MRI, allowing for comparison with the intervention group and ensuring the reliability of the diagnostic approach.",[13,14],"Diagnostic Test: MSOT with ICG","Diagnostic Test: MRI",{"label":16,"type":10,"description":17,"interventionNames":18},"Transit Disorder Group","The intervention group consists of pediatric patients suffering from chronic defecation disorders, including idiopathic chronic constipation, slow transit constipation (STC), and outlet obstruction (OO). The aim of the intervention is to assess gastrointestinal transit time and peristalsis using a novel, non-invasive combination of Multispectral Optoacoustic Tomography (MSOT) and MRI.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","MSOT with ICG","Application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"MRI","Non-invasive MRI imaging technique will be employed to assess the peristalsis of intestinal segments",[9,16],[31,34],{"name":32,"affiliation":5,"role":33},"Sonja Diez, PD Dr. med.","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Adrian Regensburger, PD Dr. med.",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Frederike Bieling","CONTACT","+49 9131 85 32923","frederike.bieling@uk-erlangen.de",{"name":32,"role":39,"phone":40,"phoneExt":25,"email":43},"sonja.diez@uk-erlangen.de",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":25},"University Hospital Erlangen, Pediatric Surgery","RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],11.00783,49.59099,{"lat":57,"lon":56},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Dr. med. Sonja Diez","PD Dr. med. Sonja Diez","100586159","msot-and-mri-for-non-invasive-assessment-of-intestinal-transit-time-in-children-with-chronic-bowel-emptying-disorders-100586159",false,"NCT06911749","MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders","Contrast Enhanced Multispectral Optoacoustic Tomography and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders","Inclusion Criteria:\n\nPatient Group\n\n* Written informed consent from the participant (starting at age 6).\n* Written informed consent from the legal guardian(s).\n* Suspected or confirmed diagnosis of chronic defecation disorder.\n* Age ≤ 18 years.\n* Willingness and ability to participate, with sufficient German language skills to understand the informed consent document.\n\nControl Group\n\n* Written informed consent from the participant.\n* Age \\> 18 years.\n* BMI \\\u003C 25 or medical suitability for MSOT examination as assessed by a physician.\n* Willingness and ability to participate, with sufficient German language skills to understand the informed consent document.\n\nExclusion Criteria:\n\n* Age \\\u003C 1 year.\n* Pregnancy or breastfeeding.\n* Tattoos in the examination area.\n* Subcutaneous fat tissue thickness \\> 3 cm.\n* Known hypersensitivity to ICG, sodium iodide, or iodine.\n* Thyroid dysfunction, including hyperthyroidism or focal\u002Fdiffuse thyroid autonomy.\n* Recent thyroid function testing with radioactive iodine treatment (within two weeks before or after the study).\n* Impaired renal function.\n* Use of specific medications, including:\n\n  * Beta-blockers,\n  * Anticonvulsants,\n  * Cyclopropane,\n  * Bisulfite compounds,\n  * Haloperidol,\n  * Heroin,\n  * Meperidine,\n  * Metamizole,\n  * Methadone,\n  * Morphine,\n  * Nitrofurantoin,\n  * Opium alkaloids,\n  * Phenobarbital,\n  * Phenylbutazone,\n  * Probenecid,\n  * Rifamycin,\n  * Any injection containing sodium bisulfite.\n* General contraindications for MRI, such as electrical implants (e.g., pacemakers, perfusion pumps).\n* Severe claustrophobia preventing MRI examination.",true,"ALL","1 Year",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","The project presented here is a monocentric clinical study conducted by the Pediatric Surgery and Pediatrics departments of the University Hospital Erlangen. The study aims to experimentally expand the diagnostic approach for patients aged 0-17 years suffering from chronic bowel emptying disorders, regardless of any underlying causal or previously treated conditions.\n\nAt the core of this clinical study is the application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time in children. Unlike conventional X-ray diagnostics, MSOT is radiation-free and considered non-invasive, although it has not yet been standardized for routine clinical use. Additionally, a contrast-free, non-invasive MRI technique will be employed to assess the peristalsis of intestinal segments.\n\nThe study aims to standardize the collection and evaluation of patient data following the administration of ICG and subsequent measurements using MSOT and MRI. The objective is to assess gastrointestinal transit time and peristalsis and, ultimately, to optimize therapy for affected patients. This is of particular importance in the coloproctology specialist consultation within the Pediatric Surgery and Pediatrics departments, as follows:\n\nIt enables differentiation between patients with slow transit constipation and outlet obstruction.\n\nIt allows for a more targeted application and evaluation of neuromodulation therapy, which is used within clinical studies.\n\nThis approach allows for the identification of specific intestinal segments with delayed transit time, enabling targeted electrical stimulation of these regions.\n\nA control group of healthy adult volunteers will participate in the study on a voluntary basis.",[81,82,83,84],"Chronic Constipation","Slow Transit Constipation","Intestinal Transit Disorder","Hirschsprungs Disease",[86,87,88,89,84],"slow transit constipation","MSOT","ICG","gastrointestinal transit","2025-08-31",{"date":92,"type":93},"2025-09-03","ACTUAL",{"date":95,"type":93},"2025-04-15",{"date":97,"type":75},"2026-06-01",{"name":61,"class":6},1]