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

December 7, 2022 updated by: Marjolein Spiering, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Eligible patients were women with one or more uterine fibroids, with a diameter between 1,5 and 12 cm, of which one was easily recognizable on ultrasound to assure the quality of the Doppler images.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
architecture
Time Frame: Day 1
architecture of vessels visible in different regions yes/no.
Day 1
presence doppler signal
Time Frame: Day 1
yes/no in different regions
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Judith Huirne, Prof., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Estimate)

December 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/494 and W20_274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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