Comparison of Three Methods for Early Detection of Breast Cancer

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

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).

Study Overview

• Status: Completed
• Conditions: Proliferative Breast Disease
• Intervention / Treatment: Diagnostic test: Contrast Enhanced imaging; Drug: Lumason

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Diagnostic test: 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.; Other Names: Lumason; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CEUS true positive diagnosis	The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.	1 year
CEUS false positive diagnosis	The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram	1 year
CEUS true negative diagnosis	The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.	1 year
CEUS false negative diagnosis	The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Katrina N. Glazebrook, M.B., Ch.B., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): October 5, 2021

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: 18-003544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No