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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04453059
Enrollment
218
Registered
2020-07-01
Start date
2021-07-01
Completion date
2022-07-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring Abdominopelvic CT With Oral Administration of Contrast

Keywords

Oral Isovue

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

Interventions

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

Sponsors

Bracco Diagnostics, Inc
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with adequate visualization of anatomic delineation of the GI tractthrough study completion, an average of 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026