A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44

October 3, 2020 updated by: Lument AB

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Department of medical imaging and function

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lumentin® 44
Contrast agent
Diagnostic test: Lumentin® 44
Contrast agent
Active Comparator: Diluted Omnipaque®
Contrast agent
Diagnostic test: Diluted Omnipaque®
Contrast agent
Active Comparator: Movprep®
Contrast agent
Diagnostic test: Movprep®
Contrast agent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative Mean Difference in Contrast Density
Time Frame: Day 1
difference in contrast density between lumen and wall (mucosal lining)
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bowel Filling Properties, Extension
Time Frame: Day 1

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:

  1. No sign of contrast agent
  2. Trace of contrast agent filling
  3. Segment filled to ca. 25%
  4. Segment filled to >25% but <50%
  5. Filled to segment filled to 50%
  6. Segment filled > 50% but <75%
  7. Segment filled to ca. 75%
  8. Segment filled to >75% but <100%
  9. 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.
Day 1
Bowel Filling Properties, Distension
Time Frame: Day 1

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:

  1. No identifiable contrast agent
  2. A minimal amount of contrast agent is identified
  3. Small amount of contrast agent, insufficient for placing a ROI of 6 mm
  4. Amount of contrast agent just allowing for a ROI of 6 mm
  5. Medium filled bowel loop
  6. Slightly better than grade 5
  7. Good filling
  8. Optimal filling
  9. 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.
Day 1
Diagnostic Ability When Examining Abdominal CT
Time Frame: Day 1

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

    5. Medium

    9. 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.
Day 1
Degradation of Contrast Agent (Lumentin® 44)
Time Frame: Day 1

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
Time Frame: Day 1

The subjects assessed taste on a five degree-scale:

  1. Very negative
  2. Negative
  3. Neutral
  4. Positive
  5. Very positive
Day 1
Subjects' Assessment of Smell of the Contrast Agent
Time Frame: Day 1

The subjects assessed taste on a five degree-scale:

  1. Very negative
  2. Negative
  3. Neutral
  4. Positive
  5. Very positive
Day 1
Subjects' Assessment of Consistency of the Contrast Agent
Time Frame: Day 1

The subjects assessed taste on a five degree-scale:

  1. Very negative
  2. Negative
  3. Neutral
  4. Positive
  5. Very positive
Day 1
Subjects' Assessment of Ability to Swallow the Contrast Agent
Time Frame: Day 1

The subjects assessed taste on a five degree-scale:

  1. Very negative
  2. Negative
  3. Neutral
  4. Positive
  5. Very positive
Day 1
Subjects' Assessment of Fullness After Drinking the Contrast Agent
Time Frame: Day 1

The subjects assessed taste on a five degree-scale:

  1. Very negative
  2. Negative
  3. Neutral
  4. Positive
  5. Very positive
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lument AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Leander, Ass. Prof., Skånes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUM-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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