Monocentric prospective study to investigate the influence of patient preparation on image quality in MRI examinations of female pelvic organs
- Conditions
- Image quality of female pelvic organs
- Registration Number
- DRKS00015796
- Lead Sponsor
- Kantonsspital Baden Institut für Radiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 78
Common inclusion criteria:
• full age
• if possible without claustrophobia
• agreement to participate as a proband in study
Study arm (procedure) related criteria:
Filling state of bladder (A):
- Existing bladder
- Present incontinence with capability to lie motionless on the back for 10 min with a moderately or completely filled bladder
Food abstention (B):
- No known health related issues that don’t allow for a 4h food abstention or that would cause hypoglycaemia (e.g., drugs that need to be taken in periods less than 4 hours, or diabetes with the risk of hypoglaecemia with concurrent intake of an antidiabetic drug)
- No gut relaxing medication, e.g., Buscopan, on the day of the examination
Timepoint within menstruation cycle (C):
- Proband in pre-menopausal state with existing cycle
- Willingness to state if hormon intake or contraception used, and if so, which drug
Common exclusion criteria:
• Known contraindications related to MRT (pacemaker, MRI unsuitable foreign material, please refer to MRT brochure)
• Pregnant women
• Intent to become pregnant during study period
• In case of high probability of unplanned pregnancy
• Women with hysterectomy
• Known or assumed non-compliance to study protocol
• Incapability of proband to understand study procedures, e.g., due to language problems, psycologic diseases, dementia, etc.
• No written consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint by procedure:<br><br>• Procedure: filling state of the bladder:<br>Endpoint: identifiability of the separating fat streak<br><br>• Procedure: food abstention:<br>Endpoint: image quality in relation to motion artefacts<br><br>• Procedure: timepoint within menstruation cycle:<br>Endpoint: change in image quality in relation to anatomy of female pelvic organs, by hormonal status
- Secondary Outcome Measures
Name Time Method Secondary exploratory endpoints by procedure:<br><br>• Procedure: filling state of the bladder:<br>Endpoints:<br>- Motion artefacts<br>- Volume measurement of the filling state of the bladder -> correlation with subjective assessment of the filling state by the patient<br>- Location/position of uterus<br>- Identifiability of the ovaries<br>- Dislocation of ovaries in relation to their normal position<br><br>• Procedure: food abstention:<br>- Influence of saturation band in the fasting state<br><br>• Procedure: timepoint within menstruation cycle:<br>Endpoints:<br>- ROI measurement (ratio between signal intensity junctional zone / myometrium<br>-Thickness of endometrium by hormonal status