Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT03326518
Status:
TERMINATED
Last Update Posted:
2020-10-27
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.fork@lumentab.com', 'phone': '+46 705336996', 'title': 'Dr Thomas Fork', 'organization': 'Lument AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Mean Difference in Contrast Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '484.0', 'spread': '192.4', 'groupId': 'OG000'}, {'value': '122.1', 'spread': '81.4', 'groupId': 'OG001'}, {'value': '64.5', 'spread': '15.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'difference in contrast density between lumen and wall (mucosal lining)', 'unitOfMeasure': 'Hounsfield units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Bowel Filling Properties, Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '61.2', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '71.8', 'spread': '10.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The bowel filling agent was distributed along the length of small bowel, i.e. the extension. The filling of each of the 5 selected sub-segments of the small bowel in terms of extension was examined on the CT-scan by 2 investigators, independently of each other, and graded using Likert scales between 1 and 9.\n\nExtension scale:\n\n1. No sign of contrast agent\n2. Trace of contrast agent filling\n3. Segment filled to ca. 25%\n4. Segment filled to \\>25% but \\<50%\n5. Filled to segment filled to 50%\n6. Segment filled \\> 50% but \\<75%\n7. Segment filled to ca. 75%\n8. Segment filled to \\>75% but \\<100%\n9. Segment filled to 100% The evaluation was made by 2 independent radiology experts. The Extension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.', 'unitOfMeasure': 'Likert Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Bowel Filling Properties, Distension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '47.0', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '8.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The bowel filling agent caused a local widening of the bowel loop, distension. The filling of each of the 5 selected sub-segments of the small bowel in terms of distension was examined on the CT-scan by both the 2 investigators independently of each other, and graded using Likert scales between 1 and 9.\n\nDistension scale:\n\n1. No identifiable contrast agent\n2. A minimal amount of contrast agent is identified\n3. Small amount of contrast agent, insufficient for placing a ROI of 6 mm\n4. Amount of contrast agent just allowing for a ROI of 6 mm\n5. Medium filled bowel loop\n6. Slightly better than grade 5\n7. Good filling\n8. Optimal filling\n9. Excellent or almost over distended The evaluation was made by 2 independent radiology experts. The Distension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.', 'unitOfMeasure': 'Likert Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Diagnostic Ability When Examining Abdominal CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '41.4', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other.\n\nThe following features were assessed:\n\n* Small bowel appearance\n* Parenchymal organs, i.e. Pancreas, ovaries, urinary bladder\n* Mesenterium and omentum using a Likert scales of 1-9 ranging, where:\n\n 1.Impossible to observe details\n\n 5\\. Medium\n\n 9\\. Excellent resolution\n\nThe evaluation was made by 2 independent radiology experts. The Diagnostic ability score is the sum of the scores of each feature from both evaluations and hence range from 6 to 54.', 'unitOfMeasure': 'Likert Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Degradation of Contrast Agent (Lumentin® 44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.647', 'spread': '0.996', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage.\n\nCoalescence:\n\n0\\. No bubbles visually detectable at the CT-scan\n\n1\\. Bubbles visually detectable at the CT-scan\n\nSyneresis or drainage:\n\n0\\. No syneresis or drainage, i.e. separation of air and liquid phases, observed\n\n1\\. Syneresis or drainage observed Signs of degradation were assessed on the CT-scan, by both Investigator and Sub-Investigator, independently of each other, in each of the 5 selected sub-segments of the small bowel.\n\nThe degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10.', 'unitOfMeasure': 'Scores on a scale (0-10)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Lumentin 44 is a foam containing air, and it could be suspected that the air bubbles would not withstand the condition in the stomach/intestines. Therefore, the end point Degradation of Contrast Agent was only valid for Lumentin 44 and it was included to prove the resisting power of Lumentin 44 and not to compare the IMP with Omnipaque or Movprep.'}, {'type': 'SECONDARY', 'title': "Subjects' Assessment of Taste of the Contrast Agent", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive', 'unitOfMeasure': 'Score (1-5)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Subjects' Assessment of Smell of the Contrast Agent", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive', 'unitOfMeasure': 'Score (1-5)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Subjects' Assessment of Consistency of the Contrast Agent", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive', 'unitOfMeasure': 'Score (1-5', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Subjects' Assessment of Ability to Swallow the Contrast Agent", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive', 'unitOfMeasure': 'Score (1-5)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Subjects' Assessment of Fullness After Drinking the Contrast Agent", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'OG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'OG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive', 'unitOfMeasure': 'Score (1-5)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'FG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'FG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lumentin® 44', 'description': 'Contrast agent\n\nLumentin® 44: Contrast agent'}, {'id': 'BG001', 'title': 'Diluted Omnipaque®', 'description': 'Contrast agent\n\nDiluted Omnipaque®: Contrast agent'}, {'id': 'BG002', 'title': 'Movprep®', 'description': 'Contrast agent\n\nMovprep®: Contrast agent'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'categories': [{'title': '18-64 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': '65-84 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': '85 years and over', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-05', 'size': 1923118, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-02T11:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Primary objective reached', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-03', 'studyFirstSubmitDate': '2017-10-17', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2017-10-25', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-03', 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Mean Difference in Contrast Density', 'timeFrame': 'Day 1', 'description': 'difference in contrast density between lumen and wall (mucosal lining)'}], 'secondaryOutcomes': [{'measure': 'Bowel Filling Properties, Extension', 'timeFrame': 'Day 1', 'description': 'The bowel filling agent was distributed along the length of small bowel, i.e. the extension. The filling of each of the 5 selected sub-segments of the small bowel in terms of extension was examined on the CT-scan by 2 investigators, independently of each other, and graded using Likert scales between 1 and 9.\n\nExtension scale:\n\n1. No sign of contrast agent\n2. Trace of contrast agent filling\n3. Segment filled to ca. 25%\n4. Segment filled to \\>25% but \\<50%\n5. Filled to segment filled to 50%\n6. Segment filled \\> 50% but \\<75%\n7. Segment filled to ca. 75%\n8. Segment filled to \\>75% but \\<100%\n9. Segment filled to 100% The evaluation was made by 2 independent radiology experts. The Extension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.'}, {'measure': 'Bowel Filling Properties, Distension', 'timeFrame': 'Day 1', 'description': 'The bowel filling agent caused a local widening of the bowel loop, distension. The filling of each of the 5 selected sub-segments of the small bowel in terms of distension was examined on the CT-scan by both the 2 investigators independently of each other, and graded using Likert scales between 1 and 9.\n\nDistension scale:\n\n1. No identifiable contrast agent\n2. A minimal amount of contrast agent is identified\n3. Small amount of contrast agent, insufficient for placing a ROI of 6 mm\n4. Amount of contrast agent just allowing for a ROI of 6 mm\n5. Medium filled bowel loop\n6. Slightly better than grade 5\n7. Good filling\n8. Optimal filling\n9. Excellent or almost over distended The evaluation was made by 2 independent radiology experts. The Distension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.'}, {'measure': 'Diagnostic Ability When Examining Abdominal CT', 'timeFrame': 'Day 1', 'description': 'Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other.\n\nThe following features were assessed:\n\n* Small bowel appearance\n* Parenchymal organs, i.e. Pancreas, ovaries, urinary bladder\n* Mesenterium and omentum using a Likert scales of 1-9 ranging, where:\n\n 1.Impossible to observe details\n\n 5\\. Medium\n\n 9\\. Excellent resolution\n\nThe evaluation was made by 2 independent radiology experts. The Diagnostic ability score is the sum of the scores of each feature from both evaluations and hence range from 6 to 54.'}, {'measure': 'Degradation of Contrast Agent (Lumentin® 44)', 'timeFrame': 'Day 1', 'description': 'Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage.\n\nCoalescence:\n\n0\\. No bubbles visually detectable at the CT-scan\n\n1\\. Bubbles visually detectable at the CT-scan\n\nSyneresis or drainage:\n\n0\\. No syneresis or drainage, i.e. separation of air and liquid phases, observed\n\n1\\. Syneresis or drainage observed Signs of degradation were assessed on the CT-scan, by both Investigator and Sub-Investigator, independently of each other, in each of the 5 selected sub-segments of the small bowel.\n\nThe degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10.'}, {'measure': "Subjects' Assessment of Taste of the Contrast Agent", 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive'}, {'measure': "Subjects' Assessment of Smell of the Contrast Agent", 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive'}, {'measure': "Subjects' Assessment of Consistency of the Contrast Agent", 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive'}, {'measure': "Subjects' Assessment of Ability to Swallow the Contrast Agent", 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive'}, {'measure': "Subjects' Assessment of Fullness After Drinking the Contrast Agent", 'timeFrame': 'Day 1', 'description': 'The subjects assessed taste on a five degree-scale:\n\n1. Very negative\n2. Negative\n3. Neutral\n4. Positive\n5. Very positive'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subjects Referred to CT-examination of the Abdomen']}, 'referencesModule': {'references': [{'pmid': '35378633', 'type': 'DERIVED', 'citation': 'Leander P, Stathis G, Casal-Dujat L, Boman K, Adnerhill I, Marsal J, Book O, Fork T. A novel food-based negative oral contrast agent compared with two conventional oral contrast agents in abdominal CT: a three-arm parallel blinded randomised controlled single-centre trial. Eur Radiol Exp. 2022 Apr 5;6(1):15. doi: 10.1186/s41747-022-00267-z.'}]}, 'descriptionModule': {'briefSummary': 'Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of either gender at least 18 years at the time of signing the informed consent.\n* Having a clinical indication for CT-examination of the abdomen\n\nExclusion Criteria:\n\n* IV administration of iodine is contraindicated\n* Known allergy to egg albumen\n* Clinical suspicion, according to medical record, of fistula formation and/or leakage\n* Referral indication of small bowel disease(s)\n* Having known manifest thyrotoxicosis\n* Having known phenylketonuria\n* Having known Glucose-6-phosphatase deficiency'}, 'identificationModule': {'nctId': 'NCT03326518', 'briefTitle': 'A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lument AB'}, 'officialTitle': 'An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.', 'orgStudyIdInfo': {'id': 'LUM-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumentin® 44', 'description': 'Contrast agent', 'interventionNames': ['Diagnostic Test: Lumentin® 44']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diluted Omnipaque®', 'description': 'Contrast agent', 'interventionNames': ['Diagnostic Test: Diluted Omnipaque®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Movprep®', 'description': 'Contrast agent', 'interventionNames': ['Diagnostic Test: Movprep®']}], 'interventions': [{'name': 'Lumentin® 44', 'type': 'DIAGNOSTIC_TEST', 'description': 'Contrast agent', 'armGroupLabels': ['Lumentin® 44']}, {'name': 'Diluted Omnipaque®', 'type': 'DIAGNOSTIC_TEST', 'description': 'Contrast agent', 'armGroupLabels': ['Diluted Omnipaque®']}, {'name': 'Movprep®', 'type': 'DIAGNOSTIC_TEST', 'description': 'Contrast agent', 'armGroupLabels': ['Movprep®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Department of medical imaging and function', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Peter Leander, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skanes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lument AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}