A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44

Study Overview
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Brief Summary
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A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis. The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality. In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.

Detailed Description
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This is an uncontrolled, single centre phase II trial. Enrolled HVs (n=10) will undergo Gd-enhanced MRE after oral intake of Lumentin® 44. Interested HVs will be identified primarily among medical students at the medical hospitals at Malmö and Lund. Posters will be placed at the departments and invitation letters will be handed out. The HVs interested in participating will be invited to attend a pre-screening visit where their suitability based on age and health status will be assessed. Fifteen HVs who fulfil the pre-screening criteria and are interested in participating will be asked to attend a screening visit at the clinic and if eligible for the trial they will then visit the clinic for the MRE assessment within 1-2 weeks. Only the initial 10 of the eligible HVs will be asked to come for the MRE examination and the remaining eligible subjects will be asked to stand by in case any of the 10 subjects are unable to come or cannot undergo the examination. HVs will be asked to fast for 6 hours prior to the examination on the day of the MRE examination. Small amount of clear liquid is allowed up to 2 decilitres. Prior to MRE, Lumentin® 44 will be provided to them in volumes of up to 1,500 mL and at least 1,100 mL of Lumentin® 44 must be drunk. The subjects will be asked to drink the solutions of oral contrast agent within 45 minutes to 1 hour. Subjects not able to drink at least 1.1 L of Lumentin® 44 will be withdrawn from the trial. Prior to the intake of Lumentin® 44, an IV antecubital cannula will be placed and used for blood sampling and administration of gadolinium (Gd) contrast agent during the MRE assessment.

Official Title
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An Uncontrolled, Single Centre, Healthy Volunteer, Phase II Proof-of-concept Trial Investigating MR-enterography Image Quality of Lumentin® 44, a New Egg Albumen Based Oral Small Bowel Filling Contrast Agent.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lumentin® 44 Powder for oral foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers of either gender at least 18 years at the time of signing the informed consent. 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). 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. Exclusion Criteria: GFR below 60 ml/min/1.73 sqm body surface. All subjects will have a plasma creatinine taken at screening for calculation of eGFR. History of drug related reaction to gadolinium contrast agents. Have had gadolinium injection during the last 4 weeks. Claustrophobia not coping with MRE examination. Metal objects and medical devices in the body not judged by the investigator to be compatible with MRE. Hypersensitivity to Buscopan® (Butylhyoscopin). Having swallowing difficulties. Known allergy to egg albumen. Known sensitivity to any of the components of the investigational product. Clinical suspicion of ongoing disease by the investigator. Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol. Previously randomized to participate in this trial. Participating in or having participated in another clinical trial within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumentin® 44<br>Lumentin® 44 Powder for oral foam | Drug: Lumentin® 44 Powder for oral foam<br>* Lumentin® 44 is a foam for oral use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual evaluation of MRE images - Motility | Motility: MRE examinations with Lumentin® 44 will be scored with respect to motility status based on a 5-graded scale, as follows: No motility could be assessed Motility is assessed to some degree but less good than conventional MRE Motility is assessed to same degree as conventional MRE Motility is assessed somewhat better than conventional MRE Motility is assessed better than conventional MRE Motility should be evaluated as a whole in the specific cine- sequences and resulting in one ordinal score 1-5. | Day 1 | 
| Visual evaluation of MRE images -artefacts | Artefacts: MRE examinations with Lumentin® 44 will be scored with respect to artefacts based on a 5-graded scale, as follows: Severe deteriorating artefacts in the interface between the lumen and wall Disturbing artefacts in the interface between the lumen and wall less good compared to conventional MRE Medium artefacts in the interface between the lumen and wall, same as for conventional MRE Small artefacts that give minimal bright edges in the interface between the lumen and wall, somewhat better than conventional MRE No artefacts and better than conventional MRE Artefacts should be evaluated as a whole in all sequences and resulting in one ordinal score 1-5. | Day 1 | 
| Visual evaluation of MRE images -mucosal evaluation | Mucosal evaluation: MRE examinations with Lumentin® 44 will be scored with respect to mucosal status based on a 5-graded scale, as follows: No mucosal folds are seen Some small mucosal folds can be discriminated Mucosal folds can be discriminated, same as for conventional MRE Small mucosal folds can be discriminated, somewhat better than for conventional MRE Mucosal folds are seen in detail and better than conventional MRE Mucosal evaluation a) coronal and b) axial T1 gradient-echo with Gd should be done and resulting in one ordinal score 1-5. | Day 1 | 
| Visual evaluation of MRE images -overall diagnostic impression | Overall diagnostic impression: MRE examinations with Lumentin® 44 will be graded for global quality of the information obtained with special reference to diagnostic purposes, as follows: Poor diagnostic quality Medium diagnostic quality, below conventional MRE Good diagnostic quality, same as for conventional MRE Very good diagnostic quality, somewhat better than conventional MRE Excellent diagnostic quality, better than conventional MRE The quality of the whole examination and what the impression is for using the examination for diagnostic purposes will be graded. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of plasma electrolytes | Concentration of plasma electrolytes including, potassium, sodium, phosphate, and calcium, as well as ionized calcium in blood samples | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) | 
| Small bowel filling properties | Measurements of extension and distension in each of 5 selected sub-segments ( duodenum, jejunum, proximal ileum, distal ileum and terminal ileum) of the small bowel .Both variables will be judged on a scale from 1 to 5, as follows: Extension: 1 is no filling and 5 is filled completely Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension | Day 1 | 
| Adverse Events | Any treatment emergent adverse events (TEAEs) and treatment emergent adverse drug reactions (TEADRs) | Day 1 |