Tomosynthesis Versus Digital Mammography in a Population-based Screening Program

NCT02590315 | Unknown Phase 4 DMC

• 1 other identifier: CPO-PROTEUSDONNA
• Study Type: interventional
• Target: 92,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

BC

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (4)

• Cancer detection rate of DBT versus DM screening

  3 years

• Recall Rate

  5 years

• False Positive Rate

  3 years

• Positive Predictive Value

  3 years

Study Arms (2)

Digital Breast Tomosynthesis - DBT

EXPERIMENTAL

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; Device: DBT

Conventional digital mammography - DM

ACTIVE COMPARATOR

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; Device: Conventional digital mammography.

Interventions

Invitation for breast screening and random allocation OTHER

Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.

Also known as: Invitation

Conventional digital mammography - DM; Digital Breast Tomosynthesis - DBT

DBT DEVICE

Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.

Also known as: Combo-mode DBT, 3D mammography

Digital Breast Tomosynthesis - DBT

Conventional digital mammography. DEVICE

Conventional digital mammography.

Also known as: DM

Conventional digital mammography - DM

Eligibility Criteria

• Age: 46 Years - 68 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: lead
• Regione Piemonte: collaborator
• im3D S.p.A.: collaborator

Study Sites (1)

Senologia Di Screening - Sscvd

Turin, Piedmont, 10126, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Random Allocation; Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alfonso Frigerio, Dr

  SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 29, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

IT (1)