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Interobserver differences for the use of elastography for diagnosing intrauterine pathology, with MRI as reference test.


- candidate number14173
- NTR NumberNTR3778
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2013
- Secondary IDs12/445 VUMC
- Public TitleInterobserver differences for the use of elastography for diagnosing intrauterine pathology, with MRI as reference test.
- Scientific TitleThe interobserver variability of elastography for the diagnosis of intrauterine pathology with MRI as gold standard.
- ACRONYM
- hypothesisBeing able to differentiate between fibroids and adenomyosis is important because the therapeutic options differ between the two. MRI is usually used for follow-up when ultrasound results are not conclusive and adenomyosis is suspected. Since uterine bleeding is a common problem and MRI is an expensive tool, a new tool is desirable. Elastography could be a valuable tool in addition to regular 2D ultrasound.
- Healt Condition(s) or Problem(s) studiedElastography, Fibroids, Adenomyosis
- Inclusion criteria1. Patients older than 18 years;
2. Patients with uterine fibroids;
3. Patients with adenomyosis;
4. Patients with a normal uterus (controle group).
- Exclusion criteria1. Patient with contraindications for MRI;
2. Patient started hormonal medication started;
3. Postmenopausal woman.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2012
- planned closingdate1-sep-2013
- Target number of participants30
- Interventions1. 2-D greyscale sonography and the elastography;
2. MRI.
- Primary outcomeThe degree of agreement for the detection of intrauterine pathology.
- Secondary outcomeThe degree of agreement of the size, type and color characteristics seen with elastography, of the abnormality and normal uteri.
- TimepointsPatients will recieve one MRI and at one timepoint sonography of the uterus.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES B. Stoelinga
- CONTACT for SCIENTIFIC QUERIES B. Stoelinga
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Samsung Medison
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD4-jan-2013 - 12-jan-2013


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