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Magnetic Resonance Imaging (MRI) of Appendicitis in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00723788
First received: July 25, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Appendicitis
 Device: MRI of the abdomen

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Diagnostic Sensitivity, specificity and accuracy of appendiceal MRI compared to ultrasound, CT scan, and gold standard of either surgical findings or clinical follow-up [ Time Frame: 6 weeks after scans obtained ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of MRI scan and effect on emergency department disposition of potential patients with appendicitis [ Time Frame: At time of scan ] [ Designated as safety issue: No ]
  • Cost-effectiveness of appendiceal MRI compared to CT scan or ultrasound [ Time Frame: At time of scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Only one arm
All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix
 Device: MRI of the abdomen
Multiple MRI pulse sequences of the abdomen

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723788

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Pranav K Vyas, MD Children's Research Institute
  More Information

Publications:

Responsible Party: Pranav Vyas, MD, Children's National Medical Center
ClinicalTrials.gov Identifier: NCT00723788     History of Changes
Other Study ID Numbers: CNMC4024
Study First Received: July 25, 2008
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Appendicitis
Children
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013