In depth analysis of biological tissue characteristics of uterine fibroids using new MRI techniques
Completed
- Conditions
- leiomyoma10046828uterine fibroid
- Registration Number
- NL-OMON42789
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Patients with a diagnosed uterine fibroid (based on anamnesis, physical examination and vaginal ultrasonography) and uterine fibroid related symptoms are included in the study.
Exclusion Criteria
• Post-menopausal patients
• Pregnant patients
• Calcified uterine fibroids
• Severe abdominal obesity
• Uterine artery embolization in medical history
• MRI contra-indications
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main exploratory study parameter is the distribution and variation of MRI<br /><br>parameters (ADC map, Ktrans map, ve, vp and T2 map), and the correlation<br /><br>between the MRI parameters and the Funaki score and clinical UFS-QoL score. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Correlation between UFS-QoL improvement after 3 months and the MRI parameters<br /><br>(ADC map, Ktrans map, ve, vp and T2 map) in medically treated patients </p><br>