ClinicalTrials.Veeva

Menu

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

G

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Withdrawn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:

  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.

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

MBI Scan & Tomosynthesis Scan
Experimental group
Description:
Patients will receive both scans.
Treatment:
Device: MBI Scan: The LumaGEM®
Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems