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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46077

Enrollment

Registered

2016-11-01

Start date

2016-11-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leiomyoma uterine fibroid

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 10 cm - Distance skin - uterine fibroid > 10 cm

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the predictive value of 3 MRI determinants for a clinical successful treatment.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results