Condition category
Urological and Genital Diseases
Date applied
01/04/2011
Date assigned
19/07/2011
Last edited
30/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Carine Martins Jarnalo

ORCID ID

Contact details

Wilhelminalaan 12
Amsterdam
1800 AM
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL32462.094.10

Study information

Scientific title

Examination of Pyelonephritis In Children with magnetic resonance imaging (MRI): a cohort study

Acronym

EPIC

Study hypothesis

Magnetic resonance imaging (MRI) can be used as an alternative to dimercaptosuccinic acid (DMSA) for the diagnosis of pyelonephritis in children.

Ethics approval

METC Noord Holland approved on 30th November 2010, ref: NL32462.094.10

Study design

Validating cohort study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pyelonephritis

Intervention

MR-imaging is performed within 8 hours of the DMSA scan. MR examinations of the abdomen and pelvis are performed with the patient in supine position and with a body phased-array coil (better signal-to-noise ratio) on a 1.5-T system (Magnetom Avanto, Siemens, Erlangen, Germany). All MR examinations are performed using a set protocol. Single-shot images (if possible with breath-hold) are made to provide a motion-insensitive image, even in the presence of severe motion. The total examination time is less than 20 min for the MRI in total.

The parents can accompany the patient during the examination. If necessary a nurse from the paediatric department may also accompany the patient.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The sensitivity, specificity, positive and negative predictive value and inter observer agreement of MRI in diagnosing acute pyelonephritis as compared to the reference standard.
1.1. The MRI findings will be compared to the findings at imaging of the standard diagnostic work-up that preceded MRI. The diagnostic value of specific MRI characteristics for pyelonephritis will be calculated. The value of diffusion-weighted imaging (DWI) will be analysed.

Secondary outcome measures

1. To determine whether MR-diffusion weighted imaging (DWI) has additional value in the imaging of pyelonephritis
2. To determine whether MRI scanning can differentiate acute pyelonephritis from renal scarring

Overall trial start date

04/04/2011

Overall trial end date

04/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients from 0 to 18 years, with:
1.1. Acute pyelonephritis, defined as a urinary tract infection (UTI) with a body temperature above 38 °C
1.2. Suspicion of acute pyelonephritis, suggested by symptoms of a UTI and flank pain
2. For young children (under the age of 1 year and in the pre-verbal phase) other clinical symptoms can suggest pyelonephritis. This is bacteriuria with either fever, vomitus, lethargia, anorexia, abdominal pain, pollakisuria or flank pain
3. Outside the study setting, the patient would have received a dimercaptosuccinic acid (DMSA) scan
4. Patients, or a legal representative, must be able to give informed consent, and the consent must be obtained prior to the MR Imaging and DMSA scanning

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Previous diagnosis of pyelonephritis
2. All contra-indications for undergoing MRI
3. A psychiatric, addictive, or any disorder that compromises the ability to give truly informed consent for participation in this study

Recruitment start date

04/04/2011

Recruitment end date

04/04/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Wilhelminalaan 12
Amsterdam
1800 AM
Netherlands

Sponsor information

Organisation

Foreest Medical School (Netherlands)

Sponsor details

26 Juni Arcadialaan 14
Amsterdam
1813 KN
Netherlands

Sponsor type

University/education

Website

http://www.foreestmedicalschool.nl

Funders

Funder type

University/education

Funder name

The Foreest institute (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes