Comparison of Three Methods for Early Detection of Breast Cancer

Early Phase 1

Completed

• Conditions: Proliferative Breast Disease
• Interventions: Diagnostic Test: Contrast Enhanced imaging; Drug: Lumason

• Registration Number: NCT03954015
• Lead Sponsor: Mayo Clinic

Brief 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).

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 Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-10-15
• Primary Completion: 2020-06-30
• Study Completion: 2021-10-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients over age 30 with suspicious BIRADS 4/5 Lesions	Lumason	Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
patients over age 30 with suspicious BIRADS 4/5 Lesions	Contrast Enhanced imaging	Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.

Primary Outcome Measures

Name	Time	Method
CEUS true positive diagnosis	1 year	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.
CEUS true negative diagnosis	1 year	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.
CEUS false negative diagnosis	1 year	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.
CEUS false positive diagnosis	1 year	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States