A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.

Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002093-32-SE

Enrollment

Registered

2019-06-28

Start date

2019-10-24

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None. Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial. Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated. MedDRA version: 22.1 Level: LLT Classification code 10011603 Term: CT scan System Organ Class: 100000004848

Interventions

Product Name: Lumentin 44 Product Code: L 44 Pharmaceutical Form: Powder for oral solution in sachet INN or Proposed INN: Egg Albumen Powder Other descriptive name: EGG WHITE PROTEIN Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects of either gender at least 18 years of age at time of signing the informed consent. 2. Subjects with a confirmed Crohn's disease (CD) diagnosis 3. Clinical indication for an MRE examination of the small bowel, i.e. need for disease status evaluation due to, for example, a relapse/flare, disease status evaluation before starting a new treatment, evaluation of therapeutic effect of given treatment, change in symptomatology, follow-up of longstanding disease, and/or pre-operative mapping/investigation 4. Females must either present a negative pregnancy test or be surgically sterile (hysterectomy or tubal ligation) or postmenopausal (i.e. experienced 12 consecutive months without menstruation) 5. Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any trial related activity is carried out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Clinical suspicion of a severe general or an acute abdominal condition (i.e. bowel obstruction, bowel perforation, severe bleeding or severe inflammation), requiring acute or subacute management. 2. Moderate to severe dysphagia 3. Known allergy to egg albumin 4. Known severe retention of urine 5. Known cardiac arrythmia 6. Having untreated glaucoma 7. Having known manifest thyrotoxicosis 8. Having known phenylketonuria 9. Having known Glucose-6-phosphatase deficiency 10. Contraindicated IV administration of contrast media used in MRE or CTE 11. Known sensitivity to any of the components of the investigational product 12. Having metallic implants incompatible with MRI examination 13. Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol 14. Previously randomised to participate in this trial 15. Patients with CD participating in, or having participated in another, clinical trial where the final trial treatment was given within the last 6 weeks. (Patients on long term maintenance dose only, may be included.)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: • To evaluate if the radiologist’s evaluation of the CTE-L enterography is at least as useful for the gastroenterologist in setting the patient’s diagnosis, as the radiologist’s evaluation of the patient’s MRI-enterography. • To compare the Radiological Crohn’s disease Activity Score (RCDAS) for the SB of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS for the SB of a routinely performed MR-enterography • To compare the Radiological Crohn’s disease Activity Score (RCDAS) for the colon of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS for the colon of a routinely performed MR-enterography • To compare CTE-L, with MRE with respect to CD activity in the terminal ileum and colon • To compare CTE-L, with MRE with respect to complications of CD ;Primary end point(s): Two investigators will evaluate both CT-enterography (CTE) and MR-enterography (MRE) from each of the patients. The evaluation will be done using the Radiological Crohn’s Disease Activity Score (RCDAS) which includes 18 evaluations. For each investigator and patient, it will be counted how many of these 18 evaluations that are exactly the same (matches) when evaluating CTE as when evaluating MRE. The percentage of matches will then be calculated and this can then result in a figure between 0% (no matching at all) and 100% (perfect matching). The mean value between the investigators for the matching percentages will be calculated for each patient and this mean value is then the primary endpoint.;Main Objective: To compare the Radiological Crohn’s disease Activity Score (RCDAS) of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS of a routinely performed MR-enterography;Timepoint(s) of evaluation of this end point: Day 1 of each investigation (CTE with Lumentin 44 and MRE respectively)	—

Measure

Time frame

Secondary Objective: • To evaluate if the radiologist’s evaluation of the CTE-L enterography is at least as useful for the gastroenterologist in setting the patient’s diagnosis, as the radiologist’s evaluation of the patient’s MRI-enterography. • To compare the Radiological Crohn’s disease Activity Score (RCDAS) for the SB of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS for the SB of a routinely performed MR-enterography • To compare the Radiological Crohn’s disease Activity Score (RCDAS) for the colon of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS for the colon of a routinely performed MR-enterography • To compare CTE-L, with MRE with respect to CD activity in the terminal ileum and colon • To compare CTE-L, with MRE with respect to complications of CD ;Primary end point(s): Two investigators will evaluate both CT-enterography (CTE) and MR-enterography (MRE) from each of the patients. The evaluation will be done using the Radiological Crohn’s Disease Activity Score (RCDAS) which includes 18 evaluations. For each investigator and patient, it will be counted how many of these 18 evaluations that are exactly the same (matches) when evaluating CTE as when evaluating MRE. The percentage of matches will then be calculated and this can then result in a figure between 0% (no matching at all) and 100% (perfect matching). The mean value between the investigators for the matching percentages will be calculated for each patient and this mean value is then the primary endpoint.;Main Objective: To compare the Radiological Crohn’s disease Activity Score (RCDAS) of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS of a routinely performed MR-enterography;Timepoint(s) of evaluation of this end point: Day 1 of each investigation (CTE with Lumentin 44 and MRE respectively)

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Secondary

Measure	Time frame
Secondary end point(s): • To evaluate if the radiologist’s evaluation of the CTE-L enterography is at least as useful for the gastroenterologist in setting the patient’s diagnosis, as the radiologist’s evaluation of the patient’s MRI-EnterographyRadiologist’s assessment of CD activity in the SB according to the RCDAS • Radiologist’s assessment of CD activity in the colon according to the RCDAS • Radiologist’s assessment of MRE and CTE images with respect to overall disease activity according to the CDMRIS scale • Radiologist’s assessment of MRE and CTE images with respect to terminal ileum disease activity according to the CDMRIS scale • Radiologist’s assessment of MRE and CTE images with respect to overall disease damage according to the Lémann Index • Gastroenterologist’s assessments of the capsule examination with respect to the following parameters: Severity of disease distribution, Stricture. Extent Rating, Disease severity according to modified Lewis score, and Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) • Gastroenterologist’s assessments of the ultrasound examination with respect to the following parameters: Bowel wall thickening and flow, presence of; ulcers, stricture, fistula, abscess, free fluid, enlarged mesenteric lymph nodes, and mesenteric hypertrophy • Subjects assessment of taste, smell, consistency, ability to swallow and fullness according to a questionnaire filled out after intake of the contrast agent • The contrast agent volume and time to drink at CTE examinations • Radiologists assessment CTE images with respect to bowel filling properties in 5 subsegments of the small bowel Safety parameters: • Any AEs • Any adverse drug reactions (ADRs) ;Timepoint(s) of evaluation of this end point: All secondary end points will be evaluated on Day 1 of each investigation. Safety parameters will be evaluated from start of intake of the first dose of contrast agent on Day 1 and until the follow-up visit on Day 14 after the second scan	—

Measure

Time frame

Secondary end point(s): • To evaluate if the radiologist’s evaluation of the CTE-L enterography is at least as useful for the gastroenterologist in setting the patient’s diagnosis, as the radiologist’s evaluation of the patient’s MRI-EnterographyRadiologist’s assessment of CD activity in the SB according to the RCDAS • Radiologist’s assessment of CD activity in the colon according to the RCDAS • Radiologist’s assessment of MRE and CTE images with respect to overall disease activity according to the CDMRIS scale • Radiologist’s assessment of MRE and CTE images with respect to terminal ileum disease activity according to the CDMRIS scale • Radiologist’s assessment of MRE and CTE images with respect to overall disease damage according to the Lémann Index • Gastroenterologist’s assessments of the capsule examination with respect to the following parameters: Severity of disease distribution, Stricture. Extent Rating, Disease severity according to modified Lewis score, and Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) • Gastroenterologist’s assessments of the ultrasound examination with respect to the following parameters: Bowel wall thickening and flow, presence of; ulcers, stricture, fistula, abscess, free fluid, enlarged mesenteric lymph nodes, and mesenteric hypertrophy • Subjects assessment of taste, smell, consistency, ability to swallow and fullness according to a questionnaire filled out after intake of the contrast agent • The contrast agent volume and time to drink at CTE examinations • Radiologists assessment CTE images with respect to bowel filling properties in 5 subsegments of the small bowel Safety parameters: • Any AEs • Any adverse drug reactions (ADRs) ;Timepoint(s) of evaluation of this end point: All secondary end points will be evaluated on Day 1 of each investigation. Safety parameters will be evaluated from start of intake of the first dose of contrast agent on Day 1 and until the follow-up visit on Day 14 after the second scan

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Countries

Sweden

Contacts

Public ContactOlof Böök

Lument AB

olof.book@lumentab.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026