MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue

Gamma Medica

Status

Withdrawn

Conditions

Breast Neoplasms

Treatments

Device: MBI Scan: The LumaGEM®

Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02013726

GMI_Sc-02

Details and patient eligibility

About

Primary:

In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis.

Secondary:

In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.

Sex

Female

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women over 25 years of age with normal or increased risk of breast cancer.
Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
No contraindications to breast MBI or breast tomosynthesis.

Exclusion criteria

Women under the age of 25.
Women who are or may be pregnant.
Women who are currently lactating or have discontinued breast feeding < 2 months prior to the study.
Male patients are excluded as subjects.
Those unable or unwilling to provide informed consent.