AppendicitisNCT00723788
Magnetic Resonance Imaging (MRI) of Appendicitis in Children
A study testing MRI of the abdomen in people with Appendicitis, run by Children's National Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- MRI of the abdomen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis
Who cannot join
- Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18
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.
- Conditions
- Appendicitis
- Being tested
- MRI of the abdomen
- Keywords
- Appendicitis, Children, Magnetic Resonance Imaging
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the abdomenDevice
Multiple MRI pulse sequences of the abdomen
| Study group | Role | What they receive |
|---|---|---|
| Only one arm | Experimental | All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix Receives: Device: MRI of the abdomen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: during diagnostic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pranav Vyas, Children's National Research Institute
- Investigators
- Pranav K Vyas, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723788
- Sponsor's protocol ID
- CNMC4024
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2008
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 9694477Hormann 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.
PubMed 12195487Pedrosa 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.
PubMed 16505393Incesu 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.
PubMed 9057512
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18
- ClinicalTrials.gov ID
- NCT00723788
- Acronym / sponsor ID
- CNMC4024
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Children, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only one arm | Experimental | Device: MRI of the abdomenAll patients enrolled will receive an MRI of the abdomen with detailed views of the appendix |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis
Key exclusion criteria (1 listed)
- Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the abdomenMultiple MRI pulse sequences of the abdomen | Device | Only one arm |
Primary outcome
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up
Time frame: during diagnostic procedure
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9694477Hormann 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.
- Background: PubMed 12195487Hormann 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.
- Background: PubMed 16505393Pedrosa 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.
- Background: PubMed 9057512Incesu 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.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pranav K Vyas, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI of the abdomen in people with Appendicitis, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up (time frame: during diagnostic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.