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Completed

NCT Number: NCT05643339

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

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.

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Key information

Conditions

Fibroid Uterus Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

microvascular flow imaging

Diagnostic Test

microvascular flow imaging

Primary outcomes

  1. reproducibility by inter- and intraobserver agreement

    Time frame: 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 outcomes

  1. penetration in centimeters

    Time frame: 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.

  2. architecture

    Time frame: Day 1

    architecture of vessels visible in different regions yes/no.

  3. presence doppler signal

    Time frame: Day 1

    yes/no in different regions

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: MVF

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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