Subjects Referred to CT-examination of the AbdomenPhase 2NCT03326518
A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
A Phase 2 study testing Lumentin® 44, Diluted Omnipaque® and Movprep® in people with Subjects Referred to CT-examination of the Abdomen, run by Lument AB at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Referred to CT-examination of the Abdomen
- What is being tested?
- Lumentin® 44, Diluted Omnipaque® and Movprep®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 28 Nov 2017to 15 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of either gender at least 18 years at the time of signing the informed consent.
- Having a clinical indication for CT-examination of the abdomen
Who cannot join
- IV administration of iodine is contraindicated
- Known allergy to egg albumen
- Clinical suspicion, according to medical record, of fistula formation and/or leakage
- Referral indication of small bowel disease(s)
- Having known manifest thyrotoxicosis
- Having known phenylketonuria
- Having known Glucose-6-phosphatase deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.
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.
- Being tested
- Lumentin® 44, Diluted Omnipaque®, Movprep®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumentin® 44Diagnostic test
Contrast agent
Diluted Omnipaque®Diagnostic test
Contrast agent
Movprep®Diagnostic test
Contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Lumentin® 44 | Experimental | Contrast agent Receives: Diagnostic Test: Lumentin® 44 |
| Diluted Omnipaque® | Active comparator | Contrast agent Receives: Diagnostic Test: Diluted Omnipaque® |
| Movprep® | Active comparator | Contrast agent Receives: Diagnostic Test: Movprep® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Mean Difference in Contrast Density
difference in contrast density between lumen and wall (mucosal lining)
Measured: Day 1
Secondary outcomes (9)
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:
- No sign of contrast agent
- Trace of contrast agent filling
- Segment filled to ca. 25%
- Segment filled to >25% but <50%
- Filled to segment filled to 50%
- Segment filled > 50% but <75%
- Segment filled to ca. 75%
- Segment filled to >75% but <100%
- 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.
Measured: 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:
- No identifiable contrast agent
- A minimal amount of contrast agent is identified
- Small amount of contrast agent, insufficient for placing a ROI of 6 mm
- Amount of contrast agent just allowing for a ROI of 6 mm
- Medium filled bowel loop
- Slightly better than grade 5
- Good filling
- Optimal filling
- 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.
Measured: 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:
- Small bowel appearance
- Parenchymal organs, i.e. Pancreas, ovaries, urinary bladder
- Mesenterium and omentum using a Likert scales of 1-9 ranging, where: 1.Impossible to observe details
- Medium
- Excellent resolution
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.
Measured: Day 1
Degradation of Contrast Agent (Lumentin® 44)
Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage.
Coalescence:
- No bubbles visually detectable at the CT-scan
- Bubbles visually detectable at the CT-scan
Syneresis or drainage:
- No syneresis or drainage, i.e. separation of air and liquid phases, observed
- 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.
Measured: Day 1
Subjects' Assessment of Taste of the Contrast Agent
The subjects assessed taste on a five degree-scale:
- Very negative
- Negative
- Neutral
- Positive
- Very positive
Measured: Day 1
Subjects' Assessment of Smell of the Contrast Agent
The subjects assessed taste on a five degree-scale:
- Very negative
- Negative
- Neutral
- Positive
- Very positive
Measured: Day 1
Subjects' Assessment of Consistency of the Contrast Agent
The subjects assessed taste on a five degree-scale:
- Very negative
- Negative
- Neutral
- Positive
- Very positive
Measured: Day 1
Subjects' Assessment of Ability to Swallow the Contrast Agent
The subjects assessed taste on a five degree-scale:
- Very negative
- Negative
- Neutral
- Positive
- Very positive
Measured: Day 1
Subjects' Assessment of Fullness After Drinking the Contrast Agent
The subjects assessed taste on a five degree-scale:
- Very negative
- Negative
- Neutral
- Positive
- Very positive
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start28 Nov 2017
- Primary completion30 Sep 2018
- Study completion15 Feb 2019
Why it stopped: Primary objective reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjects Referred to CT-examination of the AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lument AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Leander, Ass. Prof., Principal investigator, Skanes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326518
- Sponsor's protocol ID
- LUM-001
- Status last verified
- May 2020
- First submitted
- 17 Oct 2017
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35378633
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.
- ClinicalTrials.gov ID
- NCT03326518
- Acronym / sponsor ID
- LUM-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary objective reached
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lument ABIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumentin® 44 | Experimental | Diagnostic Test: Lumentin® 44Contrast agent |
| Diluted Omnipaque® | Active comparator | Diagnostic Test: Diluted Omnipaque®Contrast agent |
| Movprep® | Active comparator | Diagnostic Test: Movprep®Contrast agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects of either gender at least 18 years at the time of signing the informed consent.
- Having a clinical indication for CT-examination of the abdomen
Key exclusion criteria (7 listed)
- IV administration of iodine is contraindicated
- Known allergy to egg albumen
- Clinical suspicion, according to medical record, of fistula formation and/or leakage
- Referral indication of small bowel disease(s)
- Having known manifest thyrotoxicosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumentin® 44Contrast agent | Diagnostic test | Lumentin® 44 |
| Diluted Omnipaque®Contrast agent | Diagnostic test | Diluted Omnipaque® |
| Movprep®Contrast agent | Diagnostic test | Movprep® |
Primary outcome
Relative Mean Difference in Contrast Density
Time frame: Day 1
difference in contrast density between lumen and wall (mucosal lining)
9 secondary outcomes
Bowel Filling Properties, Extension
Time frame: Day 1
Bowel Filling Properties, Distension
Time frame: Day 1
Diagnostic Ability When Examining Abdominal CT
Time frame: Day 1
Degradation of Contrast Agent (Lumentin® 44)
Time frame: Day 1
Subjects' Assessment of Taste of the Contrast Agent
Time frame: Day 1
Subjects' Assessment of Smell of the Contrast Agent
Time frame: Day 1
Subjects' Assessment of Consistency of the Contrast Agent
Time frame: Day 1
Subjects' Assessment of Ability to Swallow the Contrast Agent
Time frame: Day 1
Subjects' Assessment of Fullness After Drinking the Contrast Agent
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35378633Leander 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Leander, Ass. Prof. principal investigator
Skanes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumentin® 44, Diluted Omnipaque® and Movprep® in people with Subjects Referred to CT-examination of the Abdomen, run by Lument AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Mean Difference in Contrast Density (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.