Study With Oral Isovue in Abdominopelvic CT

NCT04453059 — Completed, 218 participants, Bracco Diagnostics, Inc

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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)

Registry	NCT04453059
Status	Completed
Study type	Observational
Enrollment	218 (Actual)
Sponsor	Bracco Diagnostics, Inc (Industry)
Conditions	Patients Requiring Abdominopelvic CT With Oral Administration of Contrast
Interventions	Iopamidol (Drug)
Dates	start 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 in United States

-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

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+Arms and interventions

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

+Outcome measures

Primary outcomes

Proportion of patients with adequate visualization of anatomic delineation of the GI tract [through study completion, an average of 1 year]

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
Akron Children's Hospital	Akron, Ohio	United States