The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes

The Reproducibility of Microvascular Flow in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes: a Prospective Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05643339

Acronym

MVF

Enrollment

Registered

2022-12-08

Start date

2021-02-01

Completion date

2021-12-31

Last updated

2022-12-08

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

Conditions

Fibroid Uterus

Keywords

fibroid, microvascular flow, power doppler

Brief summary

The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging, 2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to investigate the added value for daily clinical practice.

Interventions

DIAGNOSTIC_TESTmicrovascular flow imaging

microvascular flow imaging

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* one or more uterine fibroids * diameter between 1,5 and 12 cm * fibroid easily recognizable on ultrasound

Exclusion criteria

* younger than 18 years * pregnancy * uterine or cervical malignancy * adenomyosis.

Design outcomes

Primary

Measure	Time frame	Description
reproducibility by inter- and intraobserver agreement	Day 1	The primary outcome was calculated by the assessment of intercorrelation coefficient (ICC) and its 95% confidence interval (CI) using a two-way mixed model. An ICC value of 0.75-1.00 indicates a good to excellent agreement(19). Bland-Altman plots showed the distribution of data.

Secondary

Measure	Time frame	Description
penetration in centimeters	Day 1	The penetration was measured along the direction of the ultrasound wave, from the probe to the deepest ultrasound signal visible, both for Microvascular Flow and power Doppler. Differences in ordinal data was tested by Mann Whitney U, non-normal continuous data by Wilcoxon rank test and normally distributed continuous data by a one sample t-test.
architecture	Day 1	architecture of vessels visible in different regions yes/no.
presence doppler signal	Day 1	yes/no in different regions

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026