Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Abnormalities

Treatments: Other: Contrast Enhanced Spectral Mammography (CESM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02406274

15-053

Details and patient eligibility

About

Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.

This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.

Enrollment: 249 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician

Exclusion criteria

• Age < 25 years old
• Male patients
• Pregnant or lactating patients
• Patients with allergy to iodinated contrast
• Patients with a history of renal disease or patients over 70 with a creatinine > 1.3. Creatinine must have been done within the last 12 weeks.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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249 participants in 1 patient group

Contrast Enhanced Spectral Mammography

Experimental group

Treatment:

Other: Contrast Enhanced Spectral Mammography (CESM)