Tomosynthesis Versus Digital Mammography in a Population-based Screening Program (ProteusDonna)

January 30, 2019 updated by: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Digital Breast Tomosynthesis Versus Digital Mammography in a Population-based Screening Program. A Controlled Randomized Multicenter Trial

Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime.

This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Design of the study This trial will involve several hospital centres within the organised breast screening in the Italian region of Piedmont.

An invitation letter to participate in a randomised screening trial comparing DBT versus DM will be mailed to all women, 46-68 years old, living in the Piedmont Region, and eligible for invitation to the regional mammography screening program. Women who attend the centres for screening and consent to the study will be randomly allocated either to DBT or DM arm.

Women in the DM arm will be screened with bilateral, two-views digital mammography examination. Women in the DBT arm will be screened with the bilateral two-views combo mode (DM and DBT images acquired in a single compression). In both screening arms, examinations will be independently read by two expert screening radiologists. In the DBT arm, each reading will be randomly allocated (on a per-case basis) to one of these three modes: DM plus DBT (DBT is read only after initial DM interpretation), DBT plus DM (DM is read only after DBT interpretation) and "concurrent mode" (both DBT and DM are read simultaneously).

In both screening arms, participants will be recalled for further examination if indicated by at least one radiologist (without consensus or arbitration). At the subsequent round all participants will be invited to DM only. Interval cancers and advanced cancers screen-detected at the next round will be recorded. Pathological and biological parameters of screen-detected cancers (e.g, stage, grading, hormone receptors, HER2) in both screening arms will be measured to investigate overdiagnosis.

With a sample size of 23,000 and 69,000 women in the DBT and DM arm respectively, the investigators will be able to observe a significant decrease in interval cancers and advanced cancers rate of at least 50% (power 80%, two tails). The collected data will be also used to perform analyses on radiological work-flow and workload, and cost-outcome and cost-effectiveness.

Study Type

Interventional

Enrollment (Anticipated)

92000

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Italy
    • Piedmont Region
      • Torino, Piedmont Region, Italy, 10126
        • Senologia Di Screening - Sscvd

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

46 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Asymptomatic women 45-68 years, residents in the Piedmont Region, attending the regional breast cancer screening program

Exclusion Criteria:

  • Personal history of breast cancer
  • A terminal illness
  • Patients who are unable to give informed consent
  • Breast implants

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Breast Tomosynthesis - DBT
Invitation for breast screening and random allocation. Participants randomised to DBT will be screened with bilateral, two-view combo mode (DBT images are obtained with DM images). DBT participants will have an additional radiation exposure for the combined DM and DBT examinations.
Other: Invitation for breast screening and random allocation
Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
Other Names:
  • Invitation
Device: DBT
Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.
Other Names:
  • Combo-mode DBT
  • 3D mammography
Active Comparator: Conventional digital mammography - DM
Invitation for breast screening and random allocation. Participants randomised to DM will be screened with bilateral, two-view DM.
Other: Invitation for breast screening and random allocation
Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
Other Names:
  • Invitation
Device: Conventional digital mammography.
Conventional digital mammography.
Other Names:
  • DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of cancers after the first study screening round. Data on interval cancers (within 24 months of a negative study examination) and on advanced screen-detected cancers at the subsequent screen among participants will be collected.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer detection rate of DBT versus DM screening
Time Frame: 3 years
3 years
Recall Rate
Time Frame: 5 years
5 years
False Positive Rate
Time Frame: 3 years
3 years
Positive Predictive Value
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Collaborators

im3D S.p.A.
Regione Piemonte

Investigators

  • Principal Investigator: Alfonso Frigerio, Dr, SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino

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

December 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPO-PROTEUSDONNA

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.

Clinical Trials on Breast Cancer

Clinical Trials on Invitation for breast screening and random allocation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe