We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnetic Resonance Imaging (MRI) of Appendicitis in Children

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.
ClinicalTrials.gov Identifier: NCT00723788
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Pranav Vyas, Children's Research Institute

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.

Condition or disease Intervention/treatment
Appendicitis Device: MRI of the abdomen

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18
Study Start Date : August 2008
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

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

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 Posted: July 29, 2008    Key Record Dates
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