A Phase 1 interventional study of Sulfur hexafluoride lipid-type A microspheres in Appendicitis Acute, sponsored by Boston Children's Hospital. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-07-17.
Sponsored by Boston Children's Hospital · Phase 1, Interventional, and Diagnostic
This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
Browse Appendicitis studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
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.
Drug: Sulfur hexafluoride lipid-type A microspheres
Contrast-enhanced US imaging of the appendix
Also known as: Lumason
Contrast-enhanced ultrasound diagnosis of acute appendicitis
The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.
Time frame: One week
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Jul 2020, 0 months.
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This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sulfur Hexafluoride