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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only one arm | Experimental | All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI of the abdomen | Device | Multiple MRI pulse sequences of the abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pranav K Vyas, MD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9694477 | Background | Hormann 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. doi: 10.2214/ajr.171.2.9694477. | |
| 12195487 | Background | Hormann 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. doi: 10.1007/s00330-002-1351-0. Epub 2002 May 9. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI of the Abdomen | All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patient referral from Emergency Department for suspected appendicitis with ultrasound and/or CT imaging request (0800 hr - 1700 hr)
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI of the Abdomen | All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures. | Posted | Number | participants | during diagnostic procedure |
|
during MRI procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI of the Abdomen | All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pranav Vyas, MD | Children's National Health System | 2024760186 | PVyas@childrensnational.org |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| 16505393 | Background | 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. doi: 10.1148/radiol.2383050146. |
| 9057512 | Background | 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. doi: 10.2214/ajr.168.3.9057512. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | CT of the Abdomen | All patients enrolled received an MRI followed in some cases by computed tomography. |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |