Magnetic Resonance Imaging (MRI) of Appendicitis in Children
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Research Institute
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 21, 2013