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Primary objective reached
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumentin® 44 | Experimental | Contrast agent |
|
| Diluted Omnipaque® | Active Comparator | Contrast agent |
|
| Movprep® | Active Comparator | Contrast agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumentin® 44 | Diagnostic Test | Contrast agent |
| |
| Diluted Omnipaque® |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Mean Difference in Contrast Density | difference in contrast density between lumen and wall (mucosal lining) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Filling Properties, Extension | 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. Extension scale:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Leander, Ass. Prof. | Skanes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of medical imaging and function | Malmö | 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35378633 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumentin® 44 | Contrast agent Lumentin® 44: Contrast agent |
| FG001 | Diluted Omnipaque® | Contrast agent Diluted Omnipaque®: Contrast agent |
| FG002 | Movprep® | Contrast agent Movprep®: Contrast agent |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumentin® 44 | Contrast agent Lumentin® 44: Contrast agent |
| BG001 | Diluted Omnipaque® | Contrast agent Diluted Omnipaque®: Contrast agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Mean Difference in Contrast Density | difference in contrast density between lumen and wall (mucosal lining) | Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Mean | Standard Deviation | Hounsfield units | Day 1 |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumentin® 44 | Contrast agent Lumentin® 44: Contrast agent | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Thomas Fork | Lument AB | +46 705336996 | thomas.fork@lumentab.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2018 | Mar 2, 2020 | Prot_SAP_000.pdf |
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| Diagnostic Test |
Contrast agent |
|
| Movprep® | Diagnostic Test | Contrast agent |
|
| Day 1 |
| Bowel Filling Properties, Distension | 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. Distension scale:
| Day 1 |
| Diagnostic Ability When Examining Abdominal CT | Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other. The following features were assessed:
The 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. | Day 1 |
| Degradation of Contrast Agent (Lumentin® 44) | Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage. Coalescence: 0. No bubbles visually detectable at the CT-scan 1. Bubbles visually detectable at the CT-scan Syneresis or drainage: 0. No syneresis or drainage, i.e. separation of air and liquid phases, observed 1. 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. The degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10. | Day 1 |
| Subjects' Assessment of Taste of the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Day 1 |
| Subjects' Assessment of Smell of the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Day 1 |
| Subjects' Assessment of Consistency of the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Day 1 |
| Subjects' Assessment of Ability to Swallow the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Day 1 |
| Subjects' Assessment of Fullness After Drinking the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Day 1 |
| Lost to Follow-up |
|
| BG002 | Movprep® | Contrast agent Movprep®: Contrast agent |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Contrast agent Movprep®: Contrast agent |
|
|
| Secondary | Bowel Filling Properties, Extension | 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. Extension scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Mean | Standard Deviation | Likert Scale score | Day 1 |
|
|
|
| Secondary | Bowel Filling Properties, Distension | 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. Distension scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Mean | Standard Deviation | Likert Scale score | Day 1 |
|
|
|
| Secondary | Diagnostic Ability When Examining Abdominal CT | Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other. The following features were assessed:
The 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. | Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Mean | Standard Deviation | Likert Scale score | Day 1 |
|
|
|
| Secondary | Degradation of Contrast Agent (Lumentin® 44) | Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage. Coalescence: 0. No bubbles visually detectable at the CT-scan 1. Bubbles visually detectable at the CT-scan Syneresis or drainage: 0. No syneresis or drainage, i.e. separation of air and liquid phases, observed 1. 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. The degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10. | 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. | Posted | Mean | Standard Deviation | Scores on a scale (0-10) | Day 1 |
|
|
|
| Secondary | Subjects' Assessment of Taste of the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Median | Full Range | Score (1-5) | Day 1 |
|
|
|
| Secondary | Subjects' Assessment of Smell of the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Median | Full Range | Score (1-5) | Day 1 |
|
|
|
| Secondary | Subjects' Assessment of Consistency of the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Median | Full Range | Score (1-5 | Day 1 |
|
|
|
| Secondary | Subjects' Assessment of Ability to Swallow the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Median | Full Range | Score (1-5) | Day 1 |
|
|
|
| Secondary | Subjects' Assessment of Fullness After Drinking the Contrast Agent | The subjects assessed taste on a five degree-scale:
| Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis. | Posted | Median | Full Range | Score (1-5) | Day 1 |
|
|
|
| 18 |
| 0 |
| 18 |
| 7 |
| 18 |
| EG001 | Diluted Omnipaque® | Contrast agent Diluted Omnipaque®: Contrast agent | 0 | 12 | 0 | 12 | 7 | 12 |
| EG002 | Movprep® | Contrast agent Movprep®: Contrast agent | 0 | 14 | 0 | 14 | 8 | 14 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
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| Between 18 and 65 years |
|
| >=65 years |
|
| 65-84 years |
|
| 85 years and over |
|
| Male |
|