Tomosynthesis as Primary Test for Breast Cancer Screening (MAITA)

Azienda USL Reggio Emilia - IRCCS

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Diagnostic Test: digital mammography; Diagnostic Test: tomosynthesis + synthetic 2D

Study type: Interventional

Funder types: Other

Identifiers

NCT04461808

RF-2016-02363686

Details and patient eligibility

About

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.

Full description

This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.

In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).

The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.

The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.

Women will be asked for informed consent when they attend the mammography. If 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.

Enrollment: 10,156 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,156 participants in 2 patient groups

Tomosynthesis + synthetic 2D

Experimental group

Description:

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.

Treatment:

Diagnostic Test: tomosynthesis + synthetic 2D

Digital Mammography

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: digital mammography