Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

NCT01669148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 496

Last updated 2017-06-14

Study results available
· View outcomes & findings →

Summary

The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

Conditions

Interventions

DEVICE

Tomosynthesis

The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).

DEVICE

Conventional

conventional (2D) imaging (standard mammography)

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Elizabeth A Rafferty, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-06-30
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01669148 on ClinicalTrials.gov