Back to resultsComparison of Three Methods for Early Detection of Breast Cancer
Primary Purpose
Proliferative Breast Disease
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Contrast Enhanced imaging
Lumason
Sponsored by
About this trial
This is an interventional diagnostic trial for Proliferative Breast Disease
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients over age 30 with suspicious BIRADS 4/5 Lesions
Arm Description
Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
Outcomes
Primary Outcome Measures
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.
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
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03954015
Brief Title
Comparison of Three Methods for Early Detection of Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Positive predictive value of CEDM in detecting lesions seen on MR
Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Breast Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients over age 30 with suspicious BIRADS 4/5 Lesions
Arm Type
Other
Arm Description
Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast Enhanced imaging
Other Intervention Name(s)
Lumason
Intervention Description
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
Drug
Intervention Name(s)
Lumason
Intervention Description
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.
Primary Outcome Measure Information:
Title
CEUS true positive diagnosis
Description
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.
Time Frame
1 year
Title
CEUS false positive diagnosis
Description
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
Time Frame
1 year
Title
CEUS true negative diagnosis
Description
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.
Time Frame
1 year
Title
CEUS false negative diagnosis
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females greater than 30 years of age
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina N. Glazebrook, M.B., Ch.B.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Comparison of Three Methods for Early Detection of Breast Cancer
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