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In depth analysis of biological tissue characteristics of uterine fibroids using new MRI techniques

In depth analysis of biological tissue characteristics of uterine fibroids using new MRI techniques - MaSS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42789
Enrollment
80
Registered
2015-06-15
Start date
2015-08-01
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

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • Post-menopausal patients • Pregnant patients • Calcified uterine fibroids • Severe abdominal obesity • Uterine artery embolization in medical history • MRI contra-indications

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)