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Withdrawn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: