Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Breast Screening

Treatments: Diagnostic Test: Contrast-Enhanced Spectral Mammography

Study type: Observational

Funder types: Other

Identifiers

NCT03929822

19-116

Details and patient eligibility

About

The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.

Enrollment: 32 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.

Exclusion criteria

• Age <30 years old
• Screening mammography with only calcifications abnormalities
• Male patients
• Pregnant or lactating patients
• Patients with any allergy to iodinated contrast
• Patients with eGFR < 45
• Patients that may be treated with radioactive iodine

Trial design

32 participants in 1 patient group

Contrast-Enhanced Spectral Mammography (CESM)

Description:

Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up. The radiologist will interpret the low energy images and record their findings.

Treatment:

Diagnostic Test: Contrast-Enhanced Spectral Mammography