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Comparison of Three Methods for Early Detection of Breast Cancer

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03954015
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
23.7
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Oct 15, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Oct 5, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Katrina N. Glazebrook, M.B., Ch.B., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03954015
    Other Study ID Numbers:
    • 18-003544
    First Posted:
    May 17, 2019
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Diseases

    Study Results

    No Results Posted as of Jan 10, 2022