Comparison of Three Methods for Early Detection of Breast Cancer

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

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2021-10-05

Brief Summary

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Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

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Detailed Description

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The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.

1. Positive predictive value of CEDM in detecting lesions seen on MR
2. Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
3. Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
4. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.

Conditions

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Proliferative Breast Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients over age 30 with suspicious BIRADS 4/5 Lesions

Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.

Group Type OTHER

Contrast Enhanced imaging

Intervention Type DIAGNOSTIC_TEST

Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.

Lumason

Intervention Type DRUG

FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.

Interventions

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Contrast Enhanced imaging

Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.

Intervention Type DIAGNOSTIC_TEST

Lumason

FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.

Intervention Type DRUG

Other Intervention Names

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Lumason

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Patients, greater than 30 years of age
* In good general health as evidenced by medical history
* BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.

Exclusion Criteria

* Patients who are less than 30 years of age
* Have known or suspected cardiac shunts
* Have history of hypersensitive allergic reactions to any imaging contrast agents
* Pregnant (a urine pregnancy test will be given at no cost to the patient)
* Are nursing babies
* Poor renal function
* Are unwilling or unable (such as having a pacemaker) to undergo a CEMR

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No