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

• Status: Completed
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lument AB
• Collaborator: Q Clinical Research AB

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