Screening for Breast Cancer With Digital Breast Tomosynthesis

March 3, 2016 updated by: Azienda Unità Sanitaria Locale Reggio Emilia

Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group

Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).

Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.

All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Study Type

Interventional

Enrollment (Anticipated)

40000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda Sanitaria Locale Reggio Emilia
        • Sub-Investigator:
          • Luisa Paterlini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

45-70 years old women invited to breast cancer screening program who accepted to participate

Exclusion Criteria:

  • previous breast cancer diagnosis
  • pregnancy or suspicion of pregnancy
  • presence of BRCA1/2 gene mutation
  • Previous Digital Breast Tomosynthesis performed
  • unable to understand informed consent
  • chemotherapy in progress
  • presence of breast implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Breast Tomosynthesis
to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
Device: Digital Breast Tomosynthesis
twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
No Intervention: standard mammography
to the control arm the usual 2D standard mammography exam will be offered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cumulative incidence of T2+ cancers after screening
Time Frame: 2 years
2 years
incidence of interval cancers
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection rate
Time Frame: 2 years
2 years
recall rate
Time Frame: baseline
baseline
Positive Predictive value
Time Frame: baseline
baseline
diagnostic agreement between tomosynthesis and 2d mammography
Time Frame: baseline
baseline
Detection rate of in situ ductal carcinoma
Time Frame: 2 years
2 years
biopsy rate
Time Frame: baseline
baseline
self-reported pain and discomfort during mammography
Time Frame: baseline
baseline
x-ray dose
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

Collaborators

Arcispedale Santa Maria Nuova-IRCCS
Regione Emilia-Romagna

Investigators

  • Principal Investigator: Pierpaolo Pattacini, MD, Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReTomo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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