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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT05643339

Collaborator

(none)

Enrollment

Location

10.9

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroid Uterus	Diagnostic Test: microvascular flow imaging

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC	Amsterdam	Noord-Holland	Netherlands	1105AZ

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marjolein Spiering, Investigator Reseach Office Womens Child Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT05643339

Other Study ID Numbers:

2017/494 and W20_274

First Posted:

Dec 8, 2022

Last Update Posted:

Dec 8, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marjolein Spiering, Investigator Reseach Office Womens Child Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

fibroid

microvascular flow

power doppler

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Dec 8, 2022