Comparison of Three Methods for Early Detection of Breast Cancer

Proliferative Breast Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954015
• Other study ID #: 18-003544
• Status: Completed
• Phase: Early Phase 1
• Start date: October 15, 2019
• Est. completion date: October 5, 2021

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 5, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases
• Proliferative Breast Disease

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials