Magnetic Resonance Imaging (MRI) of Appendicitis in Children

Appendicitis Clinical Trial

Official title:

Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723788
• Other study ID #: CNMC4024
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: November 14, 2014
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: November 2014
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Appendicitis

Intervention

Device:
• MRI of the abdomen
Multiple MRI pulse sequences of the abdomen

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up	Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)	during diagnostic procedure	No