Appendicitis
Conditions
Keywords
Appendicitis, Children, Magnetic Resonance Imaging
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.
Interventions
DEVICEMRI of the abdomen
Multiple MRI pulse sequences of the abdomen
Sponsors
Children's National Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | during diagnostic procedure | Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) |
Countries
United States
Participant flow
Recruitment details
Patient referral from Emergency Department for suspected appendicitis with ultrasound and/or CT imaging request (0800 hr - 1700 hr) Patients accrued from Aug 2008 - Apr 2010
Participants by arm
| Arm | Count |
|---|---|
| MRI of the Abdomen All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | MRI of the Abdomen |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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)
Time frame: during diagnostic procedure
Population: All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MRI of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Sensitivity | 13 participants |
| MRI of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Specificity | 19 participants |
| MRI of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | PPV | 17 participants |
| MRI of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | NPV | 16 participants |
| US of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | NPV | 18 participants |
| US of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Sensitivity | 17 participants |
| US of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | PPV | 20 participants |
| US of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Specificity | 20 participants |
| CT of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | NPV | 7 participants |
| CT of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Specificity | 7 participants |
| CT of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | PPV | 4 participants |
| CT of the Abdomen | Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Sensitivity | 4 participants |