NCT03295656

Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis Acute

Interventions

Type	Name	Description
DRUG	Sulfur hexafluoride lipid-type A microspheres	Contrast-enhanced US imaging of the appendix

Timeline

• Start date: 2020-07-15
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2017-09-28
• Last updated: 2020-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study