An interventional study of tomosynthesis + synthetic 2D and digital mammography in Breast Cancer, sponsored by Azienda USL Reggio Emilia - IRCCS. Active, not recruiting at 4 sites in Italy. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Not applicable, Interventional, and Screening
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 10,156 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 92 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
advanced cancer incidence
cumulative incidence of T2+ cancers after first screening round
Time frame: 2 years (+9 months to complete second round assessment)
advanced cancer incidence
cumulative incidence of T2+ cancers after first screening round
Time frame: 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.
Time frame: 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.
Time frame: 1 year for 45-49 years old women
overall cumulative incidence
overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography.
Time frame: 2 years (+9 months to complete second round assessment)
overall cumulative incidence
overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography.
Time frame: 4 years (+9 months to complete second round assessment)
detection rate
cancer detected by the screening round on total screened women
Time frame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
recall rate
number of women referred to assessment after the first leve screening test on total screened women
Time frame: This outcome is measured at the baseline screening.
positive predictive value
proportion of cancer among women recalled for assessment
Time frame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
Detection rate of ductal carcinoma in situ
ductal carcinoma in situ detected by the screening round on total screened women
Time frame: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
biopsy rate
number of women undergoing biopsy after the first leve screening test on total screened women
Time frame: This outcome is measured at the baseline screening.
x-ray dose
average glandular dose receive by women during first level test
Time frame: This outcome is measured at the baseline screening.
reading time
time needed to read an imaging first level examination
Time frame: This outcome is measured at the baseline screening.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Azienda USL Reggio Emilia - IRCCS