Study With Oral Isovue in Abdominopelvic CT

Patients Requiring Abdominopelvic CT With Oral Administration of Contrast Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453059
• Other study ID #: IOP-121
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2023
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Requiring Abdominopelvic CT With Oral Administration of Contrast

Intervention

Drug:
• Iopamidol
Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with adequate visualization of anatomic delineation of the GI tract		through study completion, an average of 1 year