The primary objective is to determine new biological properties of uterine fibroid tissue using advanced MRI image sequences and to correlate these properties with the currently used simple Funaki classification and with clinical symptoms.The…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main exploratory study parameter is the distribution and variation of MRI
parameters (ADC map, Ktrans map, ve, vp and T2 map), and the correlation
between the MRI parameters and the Funaki score and clinical UFS-QoL score.
Secondary outcome
Correlation between UFS-QoL improvement after 3 months and the MRI parameters
(ADC map, Ktrans map, ve, vp and T2 map) in medically treated patients
Background summary
Recent clinical inside shows that uterine fibroid tissue can be very
heterogeneous. To refine the stratification of uterine fibroids, more
biological information is needed on tissue level. Therefore, in this study we
want to analyze a completely new MRI protocol for the characterization of
uterine fibroid tissue using multiparametric MRI techniques. The biological
characterization of uterine fibroid tissue is useful knowledge in de choice and
suitability of treatment options.
Study objective
The primary objective is to determine new biological properties of uterine
fibroid tissue using advanced MRI image sequences and to correlate these
properties with the currently used simple Funaki classification and with
clinical symptoms.
The secondary objective is to determine the correlation of symptom reduction
after 3 months of medically treated patients with the in this study evaluated
new, extra MRI parameters.
Study design
The proposed research will concern a single-center, experimental explorative
research, performed on the departments of gynecology and radiology.
Study burden and risks
Patients included in this study will undergo an MRI examination before
proceeding to treatment. During this MRI, use is made of a gadolinium-based MRI
contrast agent (Dotarem). This macro-cyclic coated , intra-venous contrast
agent is routinely used in current practice and adverse effects are scarce.
Besides, patients are asked to complete the UFS-QoL questionnaire.
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Dr. Van Heesweg 2
Zwolle 8025AB
NL
Dr. Van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53499.075.15 |