E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
No disease will be studied. Lumentin 44 is a contrast agent. The techniques Computed Tomography, with Lumentin 44 as contrast agent, and Magnetic Resonance Imaging will be compared in this trial. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011603 |
E.1.2 | Term | CT scan |
E.1.2 | System Organ Class | 100000004848 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.)
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 of each investigation (CTE with Lumentin 44 and MRE respectively) |
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E.5.2 | 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)
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Within subject controlled |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |