Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
Overview
- Phase
- Phase 1
- Intervention
- Sulfur hexafluoride lipid-type A microspheres
- Conditions
- Appendicitis Acute
- Sponsor
- Boston Children's Hospital
- Locations
- 1
- Primary Endpoint
- Contrast-enhanced ultrasound diagnosis of acute appendicitis
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.
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.
Investigators
Harriet Joan Paltiel
Associate Professor of Radiology
Boston Children's Hospital
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.
Arms & Interventions
IV Contrast-Enhanced US
IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.
Intervention: Sulfur hexafluoride lipid-type A microspheres
Outcomes
Primary Outcomes
Contrast-enhanced ultrasound diagnosis of acute appendicitis
Time Frame: One week
The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.