Improving Characterization of Calcifications With Contrast-Enhanced Mammography

Mammography Clinical Trial

Official title:

Improving Characterization of Calcifications With Contrast-Enhanced Mammography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03639129
• Other study ID #: 201709088
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: May 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Mammography

Intervention

Device:
• Contrast-enhanced mammography
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

Procedure:
• Biopsy
Standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 30 days after the CEM
Secondary	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.	At the time of the CEM (day 1)
Secondary	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.	At the time of the CEM (day 1)
Secondary	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	At the time of the CEM (day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine