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

NCT05781490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-19

Study results available
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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

Interventions

DRUG

Lumentin® 44 Powder for oral foam

Lumentin® 44 is a foam for oral use.

Sponsors & Collaborators

  • Q Clinical Research AB

    collaborator INDUSTRY

  • Lument AB

    lead INDUSTRY

Principal Investigators

  • Peter Leander · PeritusClinic

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2023-02-15
Completion
2023-02-28

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05781490 on ClinicalTrials.gov