An open, randomized, controlled, single centre trial to evaluate computed tomography image quality and diagnostic feasibility of Lumentin® 44, a new egg white based oral bowel filling contrast agent, and to compare it with two commonly used contrast agents, diluted Omnipaque® and Movprep®.
- Conditions
- one.Lumentin 44 is a contrast agent and the contrast properties will be investigated in this trial. Patients referred to computerised tomography of the abdomen will be included in the trial. Neither their medical condition nor disease will be investigated.MedDRA version: 20.1Level: LLTClassification code 10011603Term: CT scanSystem Organ Class: 100000004848Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2017-002368-42-SE
- Lead Sponsor
- ument AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 88
1.Subjects 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.Having a clinical indication for CT-examination of the abdomen
4.Having fasted (drinking allowed) for at least four hours prior to the intake of the contrast agent
5.Patients participating in concurrent oncology trial must either participate in the follow up phase of the clinical trial and currently receive no trial drug treatment since at least 6 weeks, or receive a reduced maintenance dose of the trial treatment
6.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
1.IV administration of iodine is contraindicated
2.Clinical suspicion, according to medical record, of fistula formation and/or leakage
3.Having swallowing disorders preventing intake of the contrast agents
4.Referral indication of small bowel disease(s)
5.Known allergy to egg albumen
6.Known sensitivity to any of the components of the investigational product or comparators
7.Having known manifest thyrotoxicosis
8.Having known phenylketonuria
9.Having known Glucose-6-phosphatase deficiency
10.Has taken any medication, absorbed through the small bowel, less than four hours before intake of the investigational product or comparators
11.Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol
12.Previously randomised to participate in this trial
13.Participating in, or having participated in another, non-oncology clinical trial where the final trial treatment was given within the last 6 weeks
14.Participating in an oncology clinical trial where the final full (i.e. non-maintenance) trial treatment was given within the last 6 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method