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Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

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ClinicalTrials.gov Identifier: NCT03295656
Recruitment Status : Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Harriet Joan Paltiel, Boston Children’s Hospital

Brief Summary:
This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.

Condition or disease Intervention/treatment Phase
Appendicitis Acute Drug: Sulfur hexafluoride lipid-type A microspheres Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Sulfur hexafluoride lipid-type A microspheres
Contrast-enhanced US imaging of the appendix
Other Name: Lumason




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295656


Contacts
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Contact: Harriet J. Paltiel, MDCM 617-834-5558 harriet.paltiel@childrens.harvard.edu
Contact: Gail MacCallum, BS 617-355-7832

Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Contact: Harriet J. Paltiel, MDCM    617-834-5558    harriet.paltiel@childrens.harvard.edu   
Contact: Gail MacCallum, BS    617-35-57832    gail.maccallum@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Harriet Paltiel, MDCM Boston Children’s Hospital
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Responsible Party: Harriet Joan Paltiel, Associate Professor of Radiology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03295656    
Other Study ID Numbers: IRB-P00025591
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases