What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-03-31

Brief Summary

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To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).

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Detailed Description

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Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.

Conditions

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Uterine Bleeding Uterine Fibroids Adenomyosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Evaluation of MRI, US for pelvic conditions

MRI and ultrasound imaging will be used clinically to evaluate pelvic pain and abnormal uterine bleeding. The goal is to determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluating patient preference.

Group Type ACTIVE_COMPARATOR

Evaluation of MRI, US for pelvic and uterine conditions

Intervention Type PROCEDURE

Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®).

A patient survey will be included.

Patient preference MRI vs. US

We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.

Group Type ACTIVE_COMPARATOR

Patient preference between MRI and Ultrasound

Intervention Type PROCEDURE

Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound.

Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete.

Interventions

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Evaluation of MRI, US for pelvic and uterine conditions

Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®).

A patient survey will be included.

Intervention Type PROCEDURE

Patient preference between MRI and Ultrasound

Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound.

Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age or older
2. Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
3. If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).

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Exclusion Criteria

1. If you are post-menopausal(have not had a period in at least one year's time).
2. If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
3. If you are unable or unwilling to sign the informed consents
4. If you are unable to undergo the research study exams -

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No