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A Randomized, Controlled Tria...

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

NCT ID: NCT03326518

Last Updated: 2020-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2019-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Subjects Referred to CT-examination of the Abdomen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lumentin® 44

Contrast agent

Group Type EXPERIMENTAL

Lumentin® 44

Intervention Type DIAGNOSTIC_TEST

Contrast agent

Diluted Omnipaque®

Contrast agent

Group Type ACTIVE_COMPARATOR

Diluted Omnipaque®

Intervention Type DIAGNOSTIC_TEST

Contrast agent

Movprep®

Contrast agent

Group Type ACTIVE_COMPARATOR

Movprep®

Intervention Type DIAGNOSTIC_TEST

Contrast agent

Interventions

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Lumentin® 44

Contrast agent

Intervention Type DIAGNOSTIC_TEST

Diluted Omnipaque®

Contrast agent

Intervention Type DIAGNOSTIC_TEST

Movprep®

Contrast agent

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lument AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Leander, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Skanes University Hospital

Locations

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Department of medical imaging and function

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED

PMID: 35378633 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

Other Identifiers

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LUM-001

Identifier Type: -

Identifier Source: org_study_id