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

NCT05643339 | Completed

• 1 other identifier: 2017/494 and W20_274
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroid Uterus

Keywords

fibroid; microvascular flow; power doppler

Outcome Measures

Primary Outcomes (1)

• reproducibility by inter- and intraobserver agreement

  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 Outcomes (3)

• penetration in centimeters

  Day 1

• architecture

  Day 1

• presence doppler signal

  Day 1

Interventions

microvascular flow imaging DIAGNOSTIC_TEST

microvascular flow imaging

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Judith Huirne, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Reseach Office Womens Child Center

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 8, 2022
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)