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Ultrasound Imaging for Fibroids

N/A

Waitlist Available

Led By Linda McLean, PhD

Research Sponsored by Dr. Linda McLean

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Premenopausal

Must not have

Confirmed or suspected uterine cancer

Previous uterine surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use a new ultrasound technology to see if it can predict how well a patient will respond to medical treatment for uterine fibroids, which are benign tumors of the uterus.

Who is the study for?

This trial is for premenopausal women with regular menstrual cycles, aged 18 or older, who are scheduled to undergo treatment for symptomatic uterine fibroids. They must have fewer than six fibroids identified by imaging and no history of conditions that could affect tissue properties.

What is being tested?

The study is testing a new ultrasound technology called Supersonic Imagine Aixplorer SWE to measure the stiffness of uterine fibroid tissues non-invasively. It aims to see if this can predict how well medical therapies will work on these fibroids.

What are the potential side effects?

Since the intervention involves only non-invasive ultrasound imaging, there are minimal expected side effects. However, discomfort from the procedure itself may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have not gone through menopause.

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I have no history of gynecological issues.

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I am scheduled for a hysterectomy or medical therapy for uterine fibroids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with or suspected to have uterine cancer.

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I have had surgery on my uterus before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

In vivo Tissue Stiffness

Secondary study objectives

Ex vivo Tissue Stiffness

SWE Reliability

SWE Validity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention

Women Supersonic Imagine Aixplorer SWE Ultrasound Imaging on two separate occasions.

Group II: FIB-SxExperimental Treatment1 Intervention

Women receiving Supersonic Imagine Aixplorer SWE Ultrasound Imaging prior to elective hysterectomy for treatment of symptomatic uterine fibroids.

Group III: FIB-MxExperimental Treatment1 Intervention

Women receiving Supersonic Imagine Aixplorer SWE Ultrasound Imaging prior to and at two points during elective medical therapy for treatment of symptomatic uterine fibroids.

0 / 6Eligibility criteria met