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

NCT05781490 | Completed Phase 2 Results

• 2 other identifiers: LUMRIS-0012022-002193-84
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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.

  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: 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.

  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: 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.

  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: 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.

  Day 1

Secondary Outcomes (14)

• 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 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 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 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)

• Bowel Filling Properties: Extension/Duodenum

  MR examination, Day 1

Study Arms (1)

Lumentin® 44

EXPERIMENTAL

Lumentin® 44 Powder for oral foam

Drug: Lumentin® 44 Powder for oral foam

Interventions

Lumentin® 44 Powder for oral foam DRUG

Lumentin® 44 is a foam for oral use.

Lumentin® 44

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lument AB: lead
• Q Clinical Research AB: collaborator

Study Sites (1)

PeritusClinic

Lund, Skåne County, 223 63, Sweden

Location

Results Point of Contact

• Title: Dr Jan Marsal
• Organization: Lument AB

jan.marsal@med.lu.se

+46709822008

Study Officials

• Peter Leander

  PeritusClinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 23, 2023
• Study Start: January 15, 2023
• Primary Completion: February 15, 2023
• Study Completion: February 28, 2023
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-01

Locations

SE (1)