Completed

NCT Number: NCT04453059

Study With Oral Isovue in Abdominopelvic 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patients Requiring Abdominopelvic CT With Oral Administration of Contrast

Sex eligibility

All sexes

Study type

Observational

Primary location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iopamidol

Drug

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

Primary outcomes

Proportion of patients with adequate visualization of anatomic delineation of the GI tract

Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study 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)

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 1, 2020
Registry last updated: Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.