Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

NCT03295656 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IRB-P00025591
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (1)

• 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.

  One week

Study Arms (1)

IV Contrast-Enhanced US

EXPERIMENTAL

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

Interventions

Sulfur hexafluoride lipid-type A microspheres DRUG

Contrast-enhanced US imaging of the appendix

Also known as: Lumason

IV Contrast-Enhanced US

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who have had a conventional abdominal US study to rule out acute appendicitis and are scheduled for an MRI or CT examination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Harriet Paltiel, MDCM

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: July 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)