Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02869893
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2016-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics
Sponsor:
Organization:
Raw JSON
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Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point.\n\nA commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin.', 'unitOfMeasure': 'mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy participants'}, {'type': 'SECONDARY', 'title': 'Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy participants underwent MR elastography of the pancreas'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single time point, pre-secretin', 'description': 'Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups.', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 50 healthy controls recruited, complete MRE data were available for 49 subjects'}, {'type': 'SECONDARY', 'title': 'Volumetric Measurement of Pancreatic Parenchymal Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation.\n\nSecretin'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '18.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single time point, pre-secretin', 'description': 'Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI)', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Participants', 'description': 'MRCP with Secretin and MR elastography will be performed on all participants.\n\nSecretin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'participant aversion to IV', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'participant fear of MRI scanner', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Participants', 'description': 'Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation.\n\nSecretin'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6-11 years', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': '12-16 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '50 participants', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-02', 'size': 204873, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-05T14:33', 'hasProtocol': True}, {'date': '2016-06-30', 'size': 170136, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-05T14:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2016-06-05', 'resultsFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-24', 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Secreted Fluid Volume as Measured by MR-PFT', 'timeFrame': '35 minutes (20 min pre-secretin, 15 minutes post-secretin)', 'description': 'Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point.\n\nA commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin.'}], 'secondaryOutcomes': [{'measure': 'Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)', 'timeFrame': 'Single time point, pre-secretin', 'description': 'Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups.'}, {'measure': 'Volumetric Measurement of Pancreatic Parenchymal Volume', 'timeFrame': 'Single time point, pre-secretin', 'description': 'Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '23357924', 'type': 'BACKGROUND', 'citation': "Amann ST, Yadav D, Barmada MM, O'Connell M, Kennard ED, Anderson M, Baillie J, Sherman S, Romagnuolo J, Hawes RH, Alkaade S, Brand RE, Lewis MD, Gardner TB, Gelrud A, Money ME, Banks PA, Slivka A, Whitcomb DC. Physical and mental quality of life in chronic pancreatitis: a case-control study from the North American Pancreatitis Study 2 cohort. Pancreas. 2013 Mar;42(2):293-300. doi: 10.1097/MPA.0b013e31826532e7."}, {'pmid': '25556020', 'type': 'BACKGROUND', 'citation': 'Schwarzenberg SJ, Bellin M, Husain SZ, Ahuja M, Barth B, Davis H, Durie PR, Fishman DS, Freedman SD, Gariepy CE, Giefer MJ, Gonska T, Heyman MB, Himes R, Kumar S, Morinville VD, Lowe ME, Nuehring NE, Ooi CY, Pohl JF, Troendle D, Werlin SL, Wilschanski M, Yen E, Uc A. Pediatric chronic pancreatitis is associated with genetic risk factors and substantial disease burden. J Pediatr. 2015 Apr;166(4):890-896.e1. doi: 10.1016/j.jpeds.2014.11.019. Epub 2014 Dec 30.'}, {'pmid': '25310479', 'type': 'BACKGROUND', 'citation': 'Somaraju UR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2014 Oct 13;(10):CD008227. doi: 10.1002/14651858.CD008227.pub2.'}, {'pmid': '24840042', 'type': 'BACKGROUND', 'citation': 'Arya VB, Senniappan S, Demirbilek H, Alam S, Flanagan SE, Ellard S, Hussain K. Pancreatic endocrine and exocrine function in children following near-total pancreatectomy for diffuse congenital hyperinsulinism. PLoS One. 2014 May 19;9(5):e98054. doi: 10.1371/journal.pone.0098054. eCollection 2014.'}, {'pmid': '15017490', 'type': 'BACKGROUND', 'citation': "Conwell DL, Zuccaro G Jr, Vargo JJ, Morrow JB, Obuchowski N, Dumot JA, Trolli PA, Burton A, O'laughlin C, Van Lente F. An endoscopic pancreatic function test with cholecystokinin-octapeptide for the diagnosis of chronic pancreatitis. Clin Gastroenterol Hepatol. 2003 May;1(3):189-94. doi: 10.1053/cgh.2003.50028."}, {'pmid': '25630864', 'type': 'BACKGROUND', 'citation': 'Abu Dayyeh BK, Conwell D, Buttar NS, Kadilaya V, Hart PA, Baumann NA, Bick BL, Chari ST, Chowdhary S, Clain JE, Gleeson FC, Lee LS, Levy MJ, Pearson RK, Petersen BT, Rajan E, Steen H, Suleiman S, Banks PA, Vege SS, Topazian M. Pancreatic juice prostaglandin e2 concentrations are elevated in chronic pancreatitis and improve detection of early disease. Clin Transl Gastroenterol. 2015 Jan 29;6(1):e72. doi: 10.1038/ctg.2014.23.'}, {'pmid': '22228105', 'type': 'BACKGROUND', 'citation': 'Pelley JR, Gordon SR, Gardner TB. Abnormal duodenal [HCO3-] following secretin stimulation develops sooner than endocrine insufficiency in minimal change chronic pancreatitis. Pancreas. 2012 Apr;41(3):481-4. doi: 10.1097/MPA.0b013e31823a4c33.'}, {'pmid': '26001927', 'type': 'BACKGROUND', 'citation': 'Sendler M, Beyer G, Mahajan UM, Kauschke V, Maertin S, Schurmann C, Homuth G, Volker U, Volzke H, Halangk W, Wartmann T, Weiss FU, Hegyi P, Lerch MM, Mayerle J. Complement Component 5 Mediates Development of Fibrosis, via Activation of Stellate Cells, in 2 Mouse Models of Chronic Pancreatitis. Gastroenterology. 2015 Sep;149(3):765-76.e10. doi: 10.1053/j.gastro.2015.05.012. Epub 2015 May 19.'}, {'pmid': '15842594', 'type': 'BACKGROUND', 'citation': "Conwell DL, Zuccaro G, Purich E, Fein S, Vanlente F, Vargo J, Dumot J, O'laughlin C, Trolli P. The effect of moderate sedation on exocrine pancreas function in normal healthy subjects: a prospective, randomized, cross-over trial using the synthetic porcine secretin stimulated Endoscopic Pancreatic Function Test (ePFT). Am J Gastroenterol. 2005 May;100(5):1161-6. doi: 10.1111/j.1572-0241.2005.41386.x."}, {'pmid': '17387611', 'type': 'BACKGROUND', 'citation': 'Conwell DL, Zuccaro G, Purich E, Fein S, Vargo JJ, Dumot JA, VanLente F, Lopez R, Trolli P. Comparison of endoscopic ultrasound chronic pancreatitis criteria to the endoscopic secretin-stimulated pancreatic function test. Dig Dis Sci. 2007 May;52(5):1206-10. doi: 10.1007/s10620-006-9469-6. Epub 2007 Mar 27.'}, {'pmid': '20110743', 'type': 'BACKGROUND', 'citation': 'Zuccaro P, Stevens T, Repas K, Diamond R, Lopez R, Wu B, Conwell DL. Magnetic resonance cholangiopancreatography reports in the evaluation of chronic pancreatitis: a need for quality improvement. Pancreatology. 2009;9(6):764-9. doi: 10.1159/000201304. Epub 2010 Jan 21.'}, {'pmid': '26465953', 'type': 'BACKGROUND', 'citation': 'Sainani NI, Kadiyala V, Mortele K, Lee L, Suleiman S, Rosenblum J, Wang W, Banks PA, Conwell DL. Evaluation of Qualitative Magnetic Resonance Imaging Features for Diagnosis of Chronic Pancreatitis. Pancreas. 2015 Nov;44(8):1280-9. doi: 10.1097/MPA.0000000000000466.'}, {'pmid': '20187202', 'type': 'BACKGROUND', 'citation': 'Balci NC, Smith A, Momtahen AJ, Alkaade S, Fattahi R, Tariq S, Burton F. MRI and S-MRCP findings in patients with suspected chronic pancreatitis: correlation with endoscopic pancreatic function testing (ePFT). J Magn Reson Imaging. 2010 Mar;31(3):601-6. doi: 10.1002/jmri.22085.'}, {'pmid': '24497052', 'type': 'BACKGROUND', 'citation': 'Shi Y, Glaser KJ, Venkatesh SK, Ben-Abraham EI, Ehman RL. Feasibility of using 3D MR elastography to determine pancreatic stiffness in healthy volunteers. J Magn Reson Imaging. 2015 Feb;41(2):369-75. doi: 10.1002/jmri.24572. Epub 2014 Feb 5.'}, {'pmid': '26149267', 'type': 'BACKGROUND', 'citation': 'Itoh Y, Takehara Y, Kawase T, Terashima K, Ohkawa Y, Hirose Y, Koda A, Hyodo N, Ushio T, Hirai Y, Yoshizawa N, Yamashita S, Nasu H, Ohishi N, Sakahara H. Feasibility of magnetic resonance elastography for the pancreas at 3T. J Magn Reson Imaging. 2016 Feb;43(2):384-90. doi: 10.1002/jmri.24995. Epub 2015 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn more about the pancreas. The investigators want to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the pancreas. The investigators also want to figure out how much fluid the pancreas releases in response to secretin. Secretin is a chemical in the body that causes the pancreas to release fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.', 'detailedDescription': 'Introduction/Methods: Pancreatic fibrosis is the end stage of chronic pancreatitis (CP), which leads to loss of acinar volume and secretory capacity, and ultimately pancreatic insufficiency (PI). CP and congenital PI affect the pediatric population, and are both increasingly recognized in children. PI has serious negative implications on a child\'s growth and health but, if diagnosed early, PI can be treated, minimizing the detrimental effects of PI. Currently, direct pancreatic function testing (PFT) via collection of pancreatic fluid is the "gold standard" for diagnosis of PI but it is an invasive testing that may require sedation or general anesthesia. Magnetic resonance cholangiopancreatography (MRCP) with secretin administration (MR-PFT) and MR elastography (MRE) may allow non-invasive, and potentially early diagnosis of CP and PI. Currently, however, normative data with which to compare MR-PFT and MRE results in pediatric patients with suspected CP/PI is not available.\n\nAims: The investigators propose to determine the normal range for secreted pancreatic fluid volume in response to secretin administration and determine the normal range for pancreatic parenchymal stiffness in a pediatric population that is not affected by pancreatic disease. To date, the investigators have validated their MRCP technique and have successfully performed both MR-PFT and MRE in CP patients; however normative data is essential for validation of our non-invasive technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects between the ages of 6 and 15.9 years.\n2. Subjects without a documented history of (or suggestive of) pancreatic disease\n\nExclusion Criteria:\n\n1. History of pancreatic disease, liver disease, intra-abdominal neoplasm, abdominal inflammatory process such as inflammatory bowel disease (IBD), or systemic illness that may affect pancreatic state (e.g. cystic fibrosis).\n2. Subjects with surgical hardware/implanted devices making them ineligible for MRI (e.g. pacemaker or other implanted medical device not approved for MRI).\n3. Subjects who require any form of sedation or general anesthesia for MRI.\n4. Subjects unable to breath-hold for the required 15-20 second imaging sequence.\n5. Subjects who are pregnant or less than 12 months post-partum.'}, 'identificationModule': {'nctId': 'NCT02869893', 'briefTitle': 'MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Magnetic Resonance Cholangiopancreatography (MRCP): A Reliable, Non Invasive Method for Staging Chronic Pancreatitis From Minimal Change Disease to the Advanced Stages in Pediatrics', 'orgStudyIdInfo': {'id': 'CIN_MRCPStudy_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Participants', 'description': 'MRCP with Secretin and MR elastography will be performed on all participants.', 'interventionNames': ['Drug: Secretin']}], 'interventions': [{'name': 'Secretin', 'type': 'DRUG', 'otherNames': ['ChiRhoStim'], 'armGroupLabels': ['Healthy Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Maisam Abu-El-Haija, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Andrew Trout, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'ChiRhoClin, Inc.', 'class': 'INDUSTRY'}, {'name': 'The National Pancreas Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}