MRI based prognostic biomarkers for treatment success of Minimal invasive treatment for Uterine Fibroids with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU)

Completed

Conditions: leiomyoma
uterine fibroid
10046828

Registration Number: NL-OMON46077

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

Patients diagnosed with a symptomatic uterine fibroid (based on anamnesis, physical examination and vaginal ultrasonography), eligible for MR-HIFU treatment.

Exclusion Criteria

- Post menopausal patients
- Pregnant patients
- Calcified fibroids
- Severe abdominal obesity
- MRI contra indications
- Funaki type 3 uterine fibroid
- Uterine fibroid close to sciatic nerve of sacrum, interpostion of bowel or ovary.
- Uterine fibroid diameter < 1 cm or > 10 cm
- Distance skin - uterine fibroid > 10 cm

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the predictive value of 3 MRI determinants for a<br /><br>clinical successful treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To correlate these MRI parameters with histopathology.<br /><br>- The correlation between the non-perfused-volume (treated tissue volume)<br /><br>measured without the use of a contrast agent (with new MRI sequences) versus<br /><br>the gold standard (measurements after administration of a contrast agent).<br /><br>- Measuring the differences between tissue stiffness of the uterine fibroid<br /><br>before and after MR-HIFU treatment. To correlate these findings with the MR<br /><br>Imaging to predict treatment outcome and thereby maybe replace the follow-up<br /><br>MRI in the future.<br /><br>- Treatment outcomes such as treatment time, thermal dose, number of<br /><br>sonications, NPV-ratio, adverse events.</p><br>