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Magnetic Resonance Imaging (MRI) of Appendicitis in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723788
First Posted: July 29, 2008
Last Update Posted: November 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pranav Vyas, Children's Research Institute
  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: Intervention Model: Single Group Assignment
Masking: Single (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 Pranav Vyas, Children's Research Institute:

Primary Outcome Measures:
  • Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up [ Time Frame: during diagnostic procedure ]
    Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)


Enrollment: 21
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Assistant Professor of Radiology and Pediatrics, Children's Research Institute
ClinicalTrials.gov Identifier: NCT00723788     History of Changes
Other Study ID Numbers: CNMC4024
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: November 5, 2014
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases