Back to resultsImproving Characterization of Calcifications With Contrast-Enhanced Mammography
Primary Purpose
Mammography
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contrast-enhanced mammography
Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Mammography
Eligibility Criteria
Inclusion Criteria:
- Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
- At least 30 years of age.
- Able to understand and willing to sign an IRB-approved written informed consent document
- GFR ≥ 30 mL/min/1.73 m2
Exclusion Criteria:
- Pregnant
- Prior history of allergy or hypersensitivity reaction to iodinated contrast
- History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
- Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast-enhanced mammography (CME)
Arm Description
-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM.
Outcomes
Primary Outcome Measures
Evaluate risk characterization of screen-detected calcifications by CEM
-The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)
Secondary Outcome Measures
Rate of detection of additional sites of disease in the same or contralateral breast on CEM
This will be defined as presence of abnormal enhancement in the same breast at least 2 cm away from the margin of the calcifications of interest or any presence of abnormal enhancement in the contralateral breast at the time of CEM
-The reference standard in this case will also be based on pathology results from core needle biopsy (if additional biopsies are performed) or findings on surgical pathology if the patient elects for mastectomy, with the decision for core needle biopsy and lumpectomy vs mastectomy according to surgeon preference and standard of care.
Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density
-Breast density category is routinely reported in the screening mammography report and accepted categories include predominantly fatty, scattered fibroglandular densities, heterogeneously dense, and extremely dense.
Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography
-Morphology of calcifications include amorphous, coarse heterogeneous, fine pleomorphic, or fine linear branching and/or based on distribution of the calcifications as either diffuse, regional, grouped, linear, or segmental, according to the descriptors in the imaging reports
Full Information
NCT ID
NCT03639129
First Posted
July 31, 2018
Last Updated
May 10, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03639129
Brief Title
Improving Characterization of Calcifications With Contrast-Enhanced Mammography
Official Title
Improving Characterization of Calcifications With Contrast-Enhanced Mammography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funding
Study Start Date
May 31, 2019 (Anticipated)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast-enhanced mammography (CME)
Arm Type
Experimental
Arm Description
-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM.
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced mammography
Other Intervention Name(s)
CME
Intervention Description
Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Evaluate risk characterization of screen-detected calcifications by CEM
Description
-The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)
Time Frame
Up to 30 days after the CEM
Secondary Outcome Measure Information:
Title
Rate of detection of additional sites of disease in the same or contralateral breast on CEM
Description
This will be defined as presence of abnormal enhancement in the same breast at least 2 cm away from the margin of the calcifications of interest or any presence of abnormal enhancement in the contralateral breast at the time of CEM
-The reference standard in this case will also be based on pathology results from core needle biopsy (if additional biopsies are performed) or findings on surgical pathology if the patient elects for mastectomy, with the decision for core needle biopsy and lumpectomy vs mastectomy according to surgeon preference and standard of care.
Time Frame
At the time of the CEM (day 1)
Title
Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density
Description
-Breast density category is routinely reported in the screening mammography report and accepted categories include predominantly fatty, scattered fibroglandular densities, heterogeneously dense, and extremely dense.
Time Frame
At the time of the CEM (day 1)
Title
Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography
Description
-Morphology of calcifications include amorphous, coarse heterogeneous, fine pleomorphic, or fine linear branching and/or based on distribution of the calcifications as either diffuse, regional, grouped, linear, or segmental, according to the descriptors in the imaging reports
Time Frame
At the time of the CEM (day 1)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
At least 30 years of age.
Able to understand and willing to sign an IRB-approved written informed consent document
GFR ≥ 30 mL/min/1.73 m2
Exclusion Criteria:
Pregnant
Prior history of allergy or hypersensitivity reaction to iodinated contrast
History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Covington, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Improving Characterization of Calcifications With Contrast-Enhanced Mammography
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