Magnetic Resonance Imaging (MRI) of Appendicitis in Children

This study is currently recruiting participants.

Verified by Children's Research Institute, February 2009

First Received: July 25, 2008 Last Updated: February 11, 2009 History of Changes

Sponsored by:	Children's Research Institute
Information provided by:	Children's Research Institute
ClinicalTrials.gov Identifier:	NCT00723788

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

MedlinePlus related topics: Appendicitis CT Scans MRI Scans Nuclear Scans Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Single Blind (Investigator), Single Group Assignment, Safety/Efficacy Study
Official Title:	Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18

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:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Only one arm: Experimental 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

Contacts

Contact: Pranav K Vyas, MD	202-476-4229	pvyas@cnmc.org
Contact: Raymond W Sze, MD	202-476-4289	rsze@cnmc.org

Locations

United States, District of Columbia
Children's National Medical Center	Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Pranav K Vyas, MD
Sub-Investigator: Raymond W Sze, MD
Sub-Investigator: Hayder Hashim, MBBCh
Sub-Investigator: Brian Fogarty, MD
Sub-Investigator: Jennifer Chapman, MD
Sub-Investigator: Jeremiah Long, MD
Sub-Investigator: Shireen Atabaki, MD

Sponsors and Collaborators

Children's Research Institute

Investigators

Principal Investigator:

Pranav K Vyas, MD

Children's Research Institute

More Information

Publications:

Hörmann 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.

Hörmann 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. Epub 2002 May 9.

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.

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.

Responsible Party:	Children's National Medical Center ( Pranav Vyas, MD )
Study ID Numbers:	CNMC4024
Study First Received:	July 25, 2008
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00723788 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Research Institute:

Appendicitis
Children
Magnetic Resonance Imaging

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Appendicitis
Intestinal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Appendicitis

Intestinal Diseases
Gastroenteritis
Cecal Diseases

ClinicalTrials.gov processed this record on May 07, 2009