Study With Oral Isovue in Abdominopelvic CT

NCT04453059 | Completed FDA Drug

• 1 other identifier: IOP-121
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Isovue

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 1 year

Interventions

Iopamidol DRUG

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

MeSH Terms

Interventions

Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)