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Innovation in Mammography: Tomosynthesis Pathways

NCT03587259 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2018-07-16

No results posted yet for this study

Summary

The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice.

It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.

Conditions

Interventions

DIAGNOSTIC_TEST

Tomosynthesis

DBT is a x-ray examination that allows to visualize the breast on 3 planes (3D) and therefore to help to see lesions hardly visible to mammography due to the overlap of glandular tissue.

DIAGNOSTIC_TEST

2D mammography

2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.

Sponsors & Collaborators

  • Cancer Prevention and Research Institute, Italy

    lead OTHER

Principal Investigators

  • Paola Mantellini, MDr · Oncological Network, Prevention and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2020-09-01
Completion
2021-09-01

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT03587259 on ClinicalTrials.gov