Clinical trial NCT05781490: A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Lument AB
Sponsor class: INDUSTRY
Collaborators: name: Q Clinical Research AB
First posted: 2023-03-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Evaluation of MRE Images - Motility
timeFrame: Day 1
measure: Visual Evaluation of MRE Images -Artefacts
timeFrame: Day 1
measure: Visual Evaluation of MRE Images -Mucosal Evaluation
timeFrame: Day 1
measure: Visual Evaluation of MRE Images -Overall Diagnostic Impression
timeFrame: Day 1
Secondary outcomes:
measure: Concentration of Plasma Sodium
timeFrame: 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)
measure: Concentration of Plasma Potassium
timeFrame: 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)
measure: Concentration of Plasma Phosphate
timeFrame: 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)
measure: Concentration of Serum Ionized Calcium
timeFrame: 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)
measure: Bowel Filling Properties: Extension/Duodenum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Extension/Jejunum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Extension/Proximal Ileum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Extension/Distal Ileum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Extension/Terminal Ileum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Distension/Duodenum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Distension/Jejunum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Distension/Proximal Ileum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Distension/Distal Ileum
timeFrame: MR examination, Day 1
measure: Bowel Filling Properties: Distension/Terminal Ileum
timeFrame: MR examination, Day 1
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: PeritusClinic
state: Skåne
Study officials:
affiliation: PeritusClinic
name: Peter Leander
role: PRINCIPAL_INVESTIGATOR
References: