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Ultrasound Imaging for Fibroids

N/A
Waitlist Available
Led By Sukhbir S Singh, MD, FRCSC
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In vivo Tissue Stiffness
Secondary outcome measures
Ex vivo Tissue Stiffness
SWE Reliability
SWE Validity

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.

Find a Location

Who is running the clinical trial?

Dr. Linda McLeanLead Sponsor
Ottawa Hospital Research InstituteOTHER
561 Previous Clinical Trials
2,785,631 Total Patients Enrolled
The Ottawa HospitalOTHER
93 Previous Clinical Trials
62,858 Total Patients Enrolled

Media Library

Healthy Controls Clinical Trial Eligibility Overview. Trial Name: NCT03369600 — N/A
Fibroid Research Study Groups: Healthy Controls, FIB-Sx, FIB-Mx
Fibroid Clinical Trial 2023: Healthy Controls Highlights & Side Effects. Trial Name: NCT03369600 — N/A
Healthy Controls 2023 Treatment Timeline for Medical Study. Trial Name: NCT03369600 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this research endeavor commenced yet?

"As indicated on clinicaltrials.gov, the recruitment period for this trial has concluded; it was initially published on August 17th 2018 and last updated June 8th 2022. Although no longer recruiting participants, there are 47 other ongoing medical studies that require candidates to join their trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Characterisation of Uterine Fibroid Tissue Stiffness
Dr. Linda McLean 2018. "Characterisation of Uterine Fibroid Tissue Stiffness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03369600.
All > Uterine Fibroids > Uterine Fibroid
~3 spots leftby Jul 2024
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