Tomosynthesis as Primary Test for Breast Cancer Screening

NCT04461808 | Active Not Recruiting

• 1 other identifier: RF-2016-02363686
• Study Type: interventional
• Target: 10,156
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Breast Cancer

Keywords

breast cancer screening; tomosynthesis

Outcome Measures

Primary Outcomes (4)

• advanced cancer incidence

  cumulative incidence of T2+ cancers after first screening round

  2 years (+9 months to complete second round assessment)

• advanced cancer incidence

  cumulative incidence of T2+ cancers after first screening round

  4 years (+9 months to complete third round assessment)

• interval cancer incidence

  incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.

  2 years for 50-65 years old women

• interval cancer incidence

  incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.

  1 year for 45-49 years old women

Secondary Outcomes (9)

• overall cumulative incidence

  2 years (+9 months to complete second round assessment)

• overall cumulative incidence

  4 years (+9 months to complete second round assessment)

• detection rate

  This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered

• recall rate

  This outcome is measured at the baseline screening.

• positive predictive value

  This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered

Study Arms (2)

Tomosynthesis + synthetic 2D

EXPERIMENTAL

Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Diagnostic Test: tomosynthesis + synthetic 2D

Digital Mammography

ACTIVE COMPARATOR

Women will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Diagnostic Test: digital mammography

Interventions

tomosynthesis + synthetic 2D DIAGNOSTIC_TEST

Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Tomosynthesis + synthetic 2D

digital mammography DIAGNOSTIC_TEST

Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Digital Mammography

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women scheduled for a new round of mammographic screening
• resident in the province

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• AULSS 9 Scaligera di Verona: collaborator
• IRCCS Policlinico S. Donato, Milano: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (4)

Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42122, Italy

Location

IRCCS Policlinico San Donato

Milan, Italy

Location

Azienda Ospedaliera Universitaria Integrata

Verona, Italy

Location

Azienda Ulss 9 Scaligera

Verona, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to mask the intervention for the patient, care provider, and investigator. Only the assessment of one of the two co-primary outcomes, i.e. cumulative incidence of advanced breast cancer after the first round of screening, can be masked. This will be obtained through a blind review of an external panel of pathologists and radiologists reviewing cases retrieved by cancer registries.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Women 45-65 participating in the mammographic screening program will be randomized to one round of screening with tomosynthesis + synthetic 2D or with digital mammography. Then all women will be re-screened after 2 years (1 year for women 45-49) for at least one round with digital mammography.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 8, 2020
• Study Start: July 15, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2029
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

IT (4)