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

Memorial Sloan Kettering Cancer Center32 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Screening

Interventions

Contrast-Enhanced Spectral MammographyDIAGNOSTIC_TEST

A standard dose of contrast material for other contrast mammography examinations and for body CT scanning, 1.5 ml/kg of Iohexol350 will be injected intravenously (IV) using a power injection (3-4 ml/s) with a maximum does of 150 ml. The IV injection is performed while the patient is in a sitting position. The mammogram will be performed in a standing position.

Eligibility

Sex: FEMALEMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Diagnostic accuracy of CESM compared to mammography

The radiologist will interpret the low energy images and record their findings.

Time frame: 2 years

Data from ClinicalTrials.gov

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