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Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients

Primary Purpose

Crohn's Disease in Pediatric Patient

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
contrast enhanced ultrasound
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease in Pediatric Patient

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are under the age of 18
  • Patients who have Crohn's disease with colonoscopy from 2020.01-2022.02 in Severance Children Hospita

Exclusion Criteria:

  • Patients who are over the age of 18 and under the age of two
  • Patients who have other bowel disease or mass than Crohn's disease
  • High allergic sensitivity to Sonovue injection agent or sulfur hexafluoride
  • Patients who have right to left shunt, pulmonary hypertension, or systemic hypertension
  • Patients who have end stage renal or liver disease or septic shock

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CEUS

Arm Description

Outcomes

Primary Outcome Measures

feasibility of Contrast Enhanced Ultrasound (CEUS) in the assessment of Crohn's disease (CD) using endoscopy as a reference standard
Feasibility was defined as the successful examination in over 90 percent of included patients.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2020
Last Updated
December 8, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04660136
Brief Title
Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients
Official Title
Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: There is no previous contrast enhanced ultrasound (CEUS) study for pediatric Crohn disease patients. There are adult studies which included adolescent patients. More pediatric patients have been diagnosed as Crohn disease due to dietary change in Korea and it would be cost effective and clinically useful if CEUS was available in Crohn disease patients as a diagnostic and follow up tool. Objective, hypothesis: Primary Objective To prospectively examine the feasibility of Contrast Enhanced Ultrasound (CEUS) in the assessment of Crohn's disease (CD) using endoscopy as a reference standard Feasibility was defined as the successful examination in over 90% of included patients. Secondary Objective To reaffirm the dosing and safety of ultrasound contrast agent and assess the image quality of the CEUS Methodology: This is a single center prospective observational study. Pediatric patients who was first diagnosed as CD with colonoscopy are enrolled in this study, The disease activity, clinical symptoms are also investigated. Within a period of maximally two weeks from the reference ileocolonoscopy and before any therapeutic changes, the patients underwent CEUS. CEUS was performed by one different pediatric radiologist, masked to all other imaging, endoscopic, and clinical data, except diagnosis of CD. CEUS was analyzed using quantification soft-ware (Vuebox), based on ROI at the most enhanced part of the bowel wall, quantitative parameters were calculated. After the first CEUS, CEUS would be performed after one year. Pediatric population , 20 patients. Imaging procedure: Within a period of maximally two weeks from the reference ileocolonoscopy and before any therapeutic changes, the patients underwent CEUS on the same day. All studies started with a grey scale US examination to find the terminal ileum and assess wall thickness, induration of surrounding fatty tissue and enlarged lymphnodes. Stenosis and length of the pathologic bowel wall was estimated, as well as complications such as abscess formation and fistulae. The thickest segment of the terminal ileum was identified and used to perform analysis of contrast enhancement. The investigators injected the second generation, ultrasonic contrast agent (SonoVue, Bracco, Milan, Italy) as a bolus of 0.03 ml/kg through a three-way 20-gauge catheter in an antecubital vein, followed by a bolus of 5 ml saline solution (0.9% NaCl).CEUS was performed with a 7.5MHz linear probe and contrast-tuned technology, based on allow mechanical index and a real-time scan to ensure the preservation of the contrast agent. A low acoustic power setting was used, expressing a low mechanical index (MI), 0.09-0.14, of a 7.5 MHz linear probe. To assess the vascularization of the involved bowel loop, the contrast uptake over quantitative analysis of the brightness intensity was measured over a period of 40 s, in regions of interest (ROI) located manually in the intestinal wall with at least 2 cm2. The investigators used a dedicated software (Vuebox) and a time-intensity curve was automatically acquired. The quantitative measurement of the contrast uptake was obtained as the difference between the maximum enhancement value and the baseline value before the arrival of contrast. Analysis, evaluation, reporting of results: data acquisition: age, sex, initial treatment, - define involved bowel segment (5 segments: the terminal ileum, right colon (cecum and ascending), transverse colon, left colon (descending and sigmoid) and rectum), Gray scale US parameters identification of the terminal ileum, wall thickness measurement at the maximal diameter of the affected terminal ileum (pathological mural thickening defined as a wall thickness above 3 mm), evaluation of the affected bowel length, stratified wall appearance, perivisceral findings such as creeping fat and stenosis, fistula or abscess CEUS quantitative parameters, Numerous CEUS quantitative perfusion parameters can be derived from this curve. FT indicates fall time; mTTl, mean local transit time; PE, peak enhancement; RT, rise time; TTP, time to peak; WiAUC, wash-in area under the curve; WiR, wash-in rate; WiWoAUC, wash-in 1 wash-out area under the curve; WoAUC, wash-out area under the curve; and WoR, wash-out rate. Clinical and laboratory parameters (CDAI,, CRP, ESR and Calprotectin) interpretation: independent interpretation of CEUS with colonoscopy as gold standard outcome assessment Successfully complete event number without adverse events Treatment response: assessed by pediatric gastroenterologist by lab results, colonoscopy results, and patient symptom improvement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease in Pediatric Patient

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CEUS
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
contrast enhanced ultrasound
Intervention Description
We injected the second generation, ultrasonic contrast agent (SonoVue, Bracco, Milan, Italy) as a bolus of 0.03 ml/kg through a three-way 20-gauge catheter in an antecubital vein, followed by a bolus of 5 ml saline solution (0.9% NaCl).CEUS was performed with a 7.5MHz linear probe and contrast-tuned technology, based on allow mechanical index and a real-time scan to ensure the preservation of the contrast agent. A low acoustic power setting was used, expressing a low mechanical index (MI), 0.09-0.14, of a 7.5 MHz linear probe.
Primary Outcome Measure Information:
Title
feasibility of Contrast Enhanced Ultrasound (CEUS) in the assessment of Crohn's disease (CD) using endoscopy as a reference standard
Description
Feasibility was defined as the successful examination in over 90 percent of included patients.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are under the age of 18 Patients who have Crohn's disease with colonoscopy from 2020.01-2022.02 in Severance Children Hospita Exclusion Criteria: Patients who are over the age of 18 and under the age of two Patients who have other bowel disease or mass than Crohn's disease High allergic sensitivity to Sonovue injection agent or sulfur hexafluoride Patients who have right to left shunt, pulmonary hypertension, or systemic hypertension Patients who have end stage renal or liver disease or septic shock
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haesung Yoon
Phone
+82-10-9204-7549
Email
saydivine@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haesung Yoon
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haesung Yoon
Phone
+82-10-9204-7549
Email
saydivine@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients

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