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Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

Primary Purpose

Appendicitis Acute

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sulfur hexafluoride lipid-type A microspheres
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis Acute

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV Contrast-Enhanced US

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2017
Last Updated
July 15, 2020
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03295656
Brief Title
Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
Official Title
Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unanticipated delays.
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Contrast-Enhanced US
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sulfur hexafluoride lipid-type A microspheres
Other Intervention Name(s)
Lumason
Intervention Description
Contrast-enhanced US imaging of the appendix
Primary Outcome Measure Information:
Title
Contrast-enhanced ultrasound diagnosis of acute appendicitis
Description
The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriet Paltiel, MDCM
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

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