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)

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

Study Overview

• Status: Completed
• Conditions: Patients Requiring Abdominopelvic CT With Oral Administration of Contrast
• Intervention / Treatment: Drug: Iopamidol

• Study Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric patients who have previously undergone CT examination of the abdomen and pelvis with oral administration of Isovue-300 (2-3% concentration) as part of their clinical work-up.

Description

Patients will be included in the study if:

• Demographic and safety data are available for analysis
• Complete set of CT images performed after oral administration of Isovue-300 are available for assessment
• Isovue-300 was orally administered during an interval time of 60-20 minutes before the CT scanning.

Patients will be excluded from the study if:

• Oral contrast agent received within 1 week prior to the CT scan
• Undergone any abdominopelvic surgery procedure that resulted in alteration of the bowel transit time prior to the CT exam
• CT exam with oral administration of Isovue was performed because of a known or suspected condition of bowel obstruction
• Patient did not actively drink the contrast solution.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with adequate visualization of anatomic delineation of the GI tract	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Oral Isovue
• Other Study ID Numbers: IOP-121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No