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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05781490

Enrollment

Registered

2023-03-23

Start date

2023-01-15

Completion date

2023-02-28

Last updated

2024-07-19

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

Conditions

Healthy

Brief summary

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

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.

Interventions

DRUGLumentin® 44 Powder for oral foam

Lumentin® 44 is a foam for oral use.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Healthy volunteers of either gender at least 18 years at the time of signing the informed consent. 2. 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). 3. 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

1. GFR below 60 ml/min/1.73 sqm body surface. All subjects will have a plasma creatinine taken at screening for calculation of eGFR. 2. History of drug related reaction to gadolinium contrast agents. 3. Have had gadolinium injection during the last 4 weeks. 4. Claustrophobia not coping with MRE examination. 5. Metal objects and medical devices in the body not judged by the investigator to be compatible with MRE. 6. Hypersensitivity to Buscopan® (Butylhyoscopin). 7. Having swallowing difficulties. 8. Known allergy to egg albumen. 9. Known sensitivity to any of the components of the investigational product. 10. Clinical suspicion of ongoing disease by the investigator. 11. Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol. 12. Previously randomized to participate in this trial. 13. Participating in or having participated in another clinical trial within the last 4 weeks

Design outcomes

Primary

Measure	Time frame	Description
Visual Evaluation of MRE Images - Motility	Day 1	Motility: MRE examinations with Lumentin® 44 will be scored with respect to motility status based on a 5-graded scale, as follows: 1. No motility could be assessed 2. Motility is assessed to some degree but less good than conventional MRE 3. Motility is assessed to same degree as conventional MRE 4. Motility is assessed somewhat better than conventional MRE 5. 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. A high score indicate a better outcome.
Visual Evaluation of MRE Images -Artefacts	Day 1	Artefacts: MRE examinations with Lumentin® 44 will be scored with respect to artefacts based on a 5-graded scale, as follows: 1. Severe deteriorating artefacts in the interface between the lumen and wall 2. Disturbing artefacts in the interface between the lumen and wall less good compared to conventional MRE 3. Medium artefacts in the interface between the lumen and wall, same as for conventional MRE 4. Small artefacts that give minimal bright edges in the interface between the lumen and wall, somewhat better than conventional MRE 5. 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. A high score indicate a better outcome.
Visual Evaluation of MRE Images -Mucosal Evaluation	Day 1	Mucosal evaluation: MRE examinations with Lumentin® 44 will be scored with respect to mucosal status based on a 5-graded scale, as follows: 1. No mucosal folds are seen 2. Some small mucosal folds can be discriminated 3. Mucosal folds can be discriminated, same as for conventional MRE 4. Small mucosal folds can be discriminated, somewhat better than for conventional MRE 5. 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. A high score indicate a better outcome.
Visual Evaluation of MRE Images -Overall Diagnostic Impression	Day 1	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: 1. Poor diagnostic quality 2. Medium diagnostic quality, below conventional MRE 3. Good diagnostic quality, same as for conventional MRE 4. Very good diagnostic quality, somewhat better than conventional MRE 5. 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 on a scale 1-5. A high score indicate a better outcome.

Secondary

Measure	Time frame	Description
Bowel Filling Properties: Extension/Duodenum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Extension/Jejunum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Extension/Proximal Ileum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Extension/Distal Ileum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Extension/Terminal Ileum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Concentration of Plasma Sodium	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)	Concentration of plasma sodium levels over time
Bowel Filling Properties: Distension/Jejunum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Distension/Proximal Ileum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Distension/Distal Ileum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Distension/Terminal Ileum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Bowel Filling Properties: Distension/Duodenum	MR examination, Day 1	Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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
Concentration of Plasma Potassium	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)	Concentration of plasma potassium levels over time
Concentration of Plasma Phosphate	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)	Concentration of plasma phosphate levels over time
Concentration of Serum Ionized Calcium	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)	Concentration of serum ionized calcium levels over time

Countries

Sweden

Participant flow

Participants by arm

Arm	Count
Lumentin® 44 Lumentin® 44 Powder for oral foam Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.	10
Total	10

Baseline characteristics

Characteristic	Lumentin® 44	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	10 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Sweden	10 Participants	—
Sex: Female, Male Female	5 Participants	—
Sex: Female, Male Male	5 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	1 / 10
serious Total, serious adverse events	0 / 10

Outcome results

Primary

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: 1. Severe deteriorating artefacts in the interface between the lumen and wall 2. Disturbing artefacts in the interface between the lumen and wall less good compared to conventional MRE 3. Medium artefacts in the interface between the lumen and wall, same as for conventional MRE 4. Small artefacts that give minimal bright edges in the interface between the lumen and wall, somewhat better than conventional MRE 5. 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. A high score indicate a better outcome.

Time frame: Day 1

Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Lumentin® 44	Visual Evaluation of MRE Images -Artefacts	Severe deteriorating artefacts in the interface between the lumen and wall	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Artefacts	Disturbing artefacts in the interface between lumen and wall less good compared to conventional MRE	5 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Artefacts	Medium artefacts in the interface between the lumen and wall, same as for conventional MRE	5 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Artefacts	Small artefacts, minimal bright edges in the interface between lumen/wall, somewhat better than MRE	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Artefacts	No artefacts and better than conventional MRE	0 Participants

Primary

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: 1. No motility could be assessed 2. Motility is assessed to some degree but less good than conventional MRE 3. Motility is assessed to same degree as conventional MRE 4. Motility is assessed somewhat better than conventional MRE 5. 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. A high score indicate a better outcome.

Time frame: Day 1

Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Lumentin® 44	Visual Evaluation of MRE Images - Motility	No motility could be assessed	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images - Motility	Motility is assessed to some degree but less good than conventional MRE	6 Participants
Lumentin® 44	Visual Evaluation of MRE Images - Motility	Motility is assessed to same degree as conventional MRE	4 Participants
Lumentin® 44	Visual Evaluation of MRE Images - Motility	Motility is assessed somewhat better than conventional MRE	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images - Motility	Motility is assessed better than conventional MRE	0 Participants

Primary

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: 1. No mucosal folds are seen 2. Some small mucosal folds can be discriminated 3. Mucosal folds can be discriminated, same as for conventional MRE 4. Small mucosal folds can be discriminated, somewhat better than for conventional MRE 5. 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. A high score indicate a better outcome.

Time frame: Day 1

Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Lumentin® 44	Visual Evaluation of MRE Images -Mucosal Evaluation	No mucosal folds are seen	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Mucosal Evaluation	Some small mucosal folds can be discriminated	6 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Mucosal Evaluation	Mucosal folds can be discriminated, same as for conventional MRE	4 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Mucosal Evaluation	Small mucosal folds can be discriminated, somewhat better than for conventional MRE	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Mucosal Evaluation	Mucosal folds are seen in detail and better than conventional MRE	0 Participants

Primary

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: 1. Poor diagnostic quality 2. Medium diagnostic quality, below conventional MRE 3. Good diagnostic quality, same as for conventional MRE 4. Very good diagnostic quality, somewhat better than conventional MRE 5. 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 on a scale 1-5. A high score indicate a better outcome.

Time frame: Day 1

Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Lumentin® 44	Visual Evaluation of MRE Images -Overall Diagnostic Impression	Poor diagnostic quality	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Overall Diagnostic Impression	Medium diagnostic quality, below conventional MRE	7 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Overall Diagnostic Impression	Good diagnostic quality, same as for conventional MRE	3 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Overall Diagnostic Impression	Very good diagnostic quality, somewhat better than conventional MRE	0 Participants
Lumentin® 44	Visual Evaluation of MRE Images -Overall Diagnostic Impression	Excellent diagnostic quality, better than conventional MRE	0 Participants

Secondary

Bowel Filling Properties: Distension/Distal Ileum

Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. 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