NCT Number: NCT04461808
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 study is active but is not currently recruiting participants.
45 year–65 year
Female
Interventional
Not applicable
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
Time frame: 2 years (+9 months to complete second round assessment)
cumulative incidence of T2+ cancers after first screening round
Time frame: 4 years (+9 months to complete third round assessment)
cumulative incidence of T2+ cancers after first screening round
Time frame: 2 years for 50-65 years old women
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
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 (+9 months to complete second round assessment)
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)
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: This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
cancer detected by the screening round on total screened women
Time frame: This outcome is measured at the baseline screening.
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. cancer diagnosed within 9 months will be considered
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
ductal carcinoma in situ detected by the screening round on total screened women
Time frame: This outcome is measured at the baseline screening.
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.
average glandular dose receive by women during first level test
Time frame: This outcome is measured at the baseline screening.
time needed to read an imaging first level examination
Azienda USL Reggio Emilia - IRCCS
Other Gov
Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
Acronym: MAITA
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