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Magnetic Resonance Imaging (MRI) of Appendicitis in Children

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI of the abdomen
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis focused on measuring Appendicitis, Children, Magnetic Resonance Imaging

Eligibility Criteria

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

Inclusion Criteria:

  • Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis

Exclusion Criteria:

  • Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.

Sites / Locations

  • Children's National Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Only one arm

Arm Description

All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix

Outcomes

Primary Outcome Measures

Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)

Secondary Outcome Measures

Full Information

First Posted
July 25, 2008
Last Updated
November 14, 2014
Sponsor
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00723788
Brief Title
Magnetic Resonance Imaging (MRI) of Appendicitis in Children
Official Title
Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Appendicitis, Children, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Only one arm
Arm Type
Experimental
Arm Description
All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix
Intervention Type
Device
Intervention Name(s)
MRI of the abdomen
Intervention Description
Multiple MRI pulse sequences of the abdomen
Primary Outcome Measure Information:
Title
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up
Description
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Time Frame
during diagnostic procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis Exclusion Criteria: Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pranav K Vyas, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9694477
Citation
Hormann M, Paya K, Eibenberger K, Dorffner R, Lang S, Kreuzer S, Metz VM. MR imaging in children with nonperforated acute appendicitis: value of unenhanced MR imaging in sonographically selected cases. AJR Am J Roentgenol. 1998 Aug;171(2):467-70. doi: 10.2214/ajr.171.2.9694477.
Results Reference
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PubMed Identifier
12195487
Citation
Hormann M, Puig S, Prokesch SR, Partik B, Helbich TH. MR imaging of the normal appendix in children. Eur Radiol. 2002 Sep;12(9):2313-6. doi: 10.1007/s00330-002-1351-0. Epub 2002 May 9.
Results Reference
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PubMed Identifier
16505393
Citation
Pedrosa I, Levine D, Eyvazzadeh AD, Siewert B, Ngo L, Rofsky NM. MR imaging evaluation of acute appendicitis in pregnancy. Radiology. 2006 Mar;238(3):891-9. doi: 10.1148/radiol.2383050146.
Results Reference
background
PubMed Identifier
9057512
Citation
Incesu L, Coskun A, Selcuk MB, Akan H, Sozubir S, Bernay F. Acute appendicitis: MR imaging and sonographic correlation. AJR Am J Roentgenol. 1997 Mar;168(3):669-74. doi: 10.2214/ajr.168.3.9057512.
Results Reference
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Magnetic Resonance Imaging (MRI) of Appendicitis in Children

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