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Summary

This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.

Conditions

Appendicitis Acute

Recruitment Status

Withdrawn

Detailed Description

Acute appendicitis is the most common surgical emergency in children. Diagnostic evaluation for possible appendicitis frequently leads to imaging studies. Magnetic resonance imaging (MRI) and computed tomography (CT) are currently the gold-standard techniques for the diagnosis or exclusion of acute appendicitis. However, these methods not always immediately available; may require administration of intravenous contrast material with the potential for allergic reactions and nephrotoxicity; and, in the case of CT, requires the administration of ionizing radiation that is linked to the long-term development of radiation-induced cancers. The current study will evaluate a potentially safer, radiation-free diagnostic method for acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of visualizing the appendix than conventional US imaging.

Eligibility Criteria

Inclusion Criteria:

Children who have had a conventional abdominal US study to rule out acute appendicitis and are scheduled for an MRI or CT examination.

Exclusion Criteria:

Children with serious comorbid conditions, including but not restricted to severe cardiac, pulmonary, renal, or hepatic disease; prior bone marrow or solid organ transplant; cancer; or presence of a ventriculoperitoneal shunt.
Children with an allergy to either the active or inactive components of Lumason.
Pregnant or nursing patients.

Intervention

Intervention Type

Intervention Name

Drug

Sulfur hexafluoride lipid-type A microspheres

Phase

Phase 1

Gender

All

Min Age

8 Years

Max Age

17 Years

Download Date

July 17, 2020

Principal Investigator

Harriet Joan Paltiel

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: