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

NCT02013726 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-08-25

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

MBI Scan: The LumaGEM®

The LumaGEM Scanner is a dual-head, MBI scanner that has previously been cleared for medical marketing (510(k) number K111791), and has been used to image more than 5,000 patients to date. The LumaGEM MBI scanner is used as a diagnostic adjunct to mammography screening for problem cases The efficacy of MBI has been well documented in clinical trials. The LumaGEM MBI scanner is a dual-head, small field-of-view (FOV) device for developing an MBI image of Tc99m-Sestamibi uptake within the breast. The device consists of solid-state detectors, a data acquisition system, and a computer. The detectors are also used to immobilize the breast during image acquisition by mild compression. The detectors are housed in two heads that are positioned on both sides of a compressed breast.

DEVICE

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

The breast tomosynthesis procedure involves x-ray imaging of the breast using a moving x-ray source and digital detectors composed of cesium iodide crystals on an amorphous silicon layer or of solely selenium in order to produce an image of the breast. This procedure is considered to basically be a modification of mammography and also is used as a diagnostic adjunct to mammography screening for problem cases.

Sponsors & Collaborators

  • Gamma Medica, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-10-31
Completion
2017-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013726 on ClinicalTrials.gov