Magnetic Resonance Imaging (MRI) of Appendicitis in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Research Institute.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014