What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

University of Michigan

Status and phase: Completed; Early Phase 1

Conditions: Uterine Bleeding; Uterine Fibroids; Adenomyosis

Treatments: Procedure: Patient preference between MRI and Ultrasound; Procedure: Evaluation of MRI, US for pelvic and uterine conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT01992718

HUM00076620

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

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 -

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Evaluation of MRI, US for pelvic conditions

Active Comparator group

Description:

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.

Treatment:

Procedure: Evaluation of MRI, US for pelvic and uterine conditions

Patient preference MRI vs. US

Active Comparator group

Description:

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

Treatment:

Procedure: Patient preference between MRI and Ultrasound