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

Not Applicable

Withdrawn

• Conditions: Breast Neoplasms

• Registration Number: NCT02013726
• Lead Sponsor: Gamma Medica, Inc.

Brief Summary

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:

1. 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.

2. 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.

3. Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25
• Study Start: 2015-04
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity/Cancer detection	12 months	Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).

Secondary Outcome Measures

Name	Time	Method
Specificity	12 months	Specificity being the total number of scans read or labeled as negative (by a radiologist) divided by number of total women without cancer. This "ground truth" of a true negative will involve in a second negative imaging scan at 12 months (follow-up exam).