- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295656
Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
July 15, 2020 updated by: Harriet Joan Paltiel, Boston Children's Hospital
This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Contrast-enhanced US imaging of the appendix
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harriet Paltiel, MDCM, Boston Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2020
Primary Completion (Actual)
July 15, 2020
Study Completion (Actual)
July 15, 2020
Study Registration Dates
First Submitted
September 25, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00025591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Appendicitis Acute
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North Estonia Medical CentreTartu University HospitalRecruitingAcute Appendicitis | Appendicitis Acute | Appendicitis Perforated | Acute Appendicitis With Rupture | Appendicitis; Perforation | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessEstonia
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Pirogov Russian National Research Medical UniversityCompletedAcute Appendicitis | Acute Appendicitis With Rupture | Acute Appendicitis Without Peritonitis | Acute Appendicitis With PeritonitisRussian Federation
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HJ23Hospital Universitari Joan XXIII de Tarragona.Not yet recruitingAcute Appendicitis | Appendicitis Perforated | Appendicitis Suppurative
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-
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