A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44

Lument

Status and phase: Terminated; Phase 2

Conditions: Subjects Referred to CT-examination of the Abdomen

Treatments: Diagnostic Test: Movprep®; Diagnostic Test: Lumentin® 44; Diagnostic Test: Diluted Omnipaque®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03326518

LUM-001

Details and patient eligibility

About

Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of either gender at least 18 years at the time of signing the informed consent.
• Having a clinical indication for CT-examination of the abdomen

Exclusion criteria

• IV administration of iodine is contraindicated
• Known allergy to egg albumen
• Clinical suspicion, according to medical record, of fistula formation and/or leakage
• Referral indication of small bowel disease(s)
• Having known manifest thyrotoxicosis
• Having known phenylketonuria
• Having known Glucose-6-phosphatase deficiency

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Lumentin® 44

Experimental group

Description:

Contrast agent

Treatment:

Diagnostic Test: Lumentin® 44

Diluted Omnipaque®

Active Comparator group

Description:

Contrast agent

Treatment:

Diagnostic Test: Diluted Omnipaque®

Movprep®

Active Comparator group

Description:

Contrast agent

Treatment:

Diagnostic Test: Movprep®