NCT04453059

Study With Oral Isovue in Abdominopelvic CT

A Phase IIIB, Multicenter Study With Oral Administration of Isovue-300 for Opacification and Delineation of the Gastrointestinal (GI) Tract in Abdominopelvic Computed Tomography (CT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 218 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This is a retrospective clinical study with prospectively designed blinded evaluation of CT images in adult and pediatric patients who underwent CT examinations of the abdomen and pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to distinguish it from adjacent abdominal and pelvic structures. The study will collect already existing data, such as demographic data, adverse events and CT images, for all chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively defined in this protocol

Conditions

• Patients Requiring Abdominopelvic CT With Oral Administration of Contrast

Interventions

Type	Name	Description
DRUG	Iopamidol	Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-07-01
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study