Improving Characterization of Calcifications With Contrast-Enhanced Mammography

The Washington University

Status: Withdrawn

Conditions: Mammography

Treatments: Procedure: Biopsy; Device: Contrast-enhanced mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT03639129

201709088

Details and patient eligibility

About

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.

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Contrast-enhanced mammography (CME)

Experimental group

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.

Treatment:

Device: Contrast-enhanced mammography

Procedure: Biopsy