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Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

NCT03295656 — Phase 1, Withdrawn, Boston Children's Hospital

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RegistryNCT03295656
StatusWithdrawn - Unanticipated delays.
PhasePhase 1
Study typeInterventional; na, single group, masking: none, diagnostic
SponsorBoston Children's Hospital (Other)
ConditionsAppendicitis Acute
InterventionsSulfur hexafluoride lipid-type A microspheres (Drug)
Datesstart 2020-07-15, primary completion 2020-07-15, completion 2020-07-15, first posted 2017-09-28, last updated 2020-07-17
Locations1 site in United States

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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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
IV Contrast-Enhanced USExperimentalDrug: Sulfur hexafluoride lipid-type A microspheresIV 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.
  • Sulfur hexafluoride lipid-type A microspheres (Drug), also known as Lumason: Contrast-enhanced US imaging of the appendix

+Outcome measures

Primary outcomes

  • Contrast-enhanced ultrasound diagnosis of acute appendicitis [One week]: The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.

+Eligibility

Sex: All, ages: 8 Years to 17 Years

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.

+Locations (1)

FacilityCityCountryStatus
Boston Children's HospitalBoston, MassachusettsUnited States

+Investigators

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