Tomosynthesis as Primary Test for Breast Cancer Screening

Breast Cancer Clinical Trial

— MAITA  

Official title:

Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04461808
• Other study ID #: RF-2016-02363686
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: April 30, 2029

Study information

• Verified date: July 2023
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10156
• Est. completion date: April 30, 2029
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• tomosynthesis + synthetic 2D
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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	Milano
Italy	Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia	Reggio Emilia
Italy	Azienda Ospedaliera Universitaria Integrata	Verona
Italy	Azienda Ulss 9 Scaligera	Verona

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia	AULSS 9 Scaligera di Verona, Azienda Ospedaliera Universitaria Integrata Verona, IRCCS Policlinico S. Donato, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	advanced cancer incidence	cumulative incidence of T2+ cancers after first screening round	2 years (+9 months to complete second round assessment)
Primary	advanced cancer incidence	cumulative incidence of T2+ cancers after first screening round	4 years (+9 months to complete third round assessment)
Primary	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
Primary	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	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.	2 years (+9 months to complete second round assessment)
Secondary	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.	4 years (+9 months to complete second round assessment)
Secondary	detection rate	cancer detected by the screening round on total screened women	This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
Secondary	recall rate	number of women referred to assessment after the first leve screening test on total screened women	This outcome is measured at the baseline screening.
Secondary	positive predictive value	proportion of cancer among women recalled for assessment	This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
Secondary	Detection rate of ductal carcinoma in situ	ductal carcinoma in situ detected by the screening round on total screened women	This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered
Secondary	biopsy rate	number of women undergoing biopsy after the first leve screening test on total screened women	This outcome is measured at the baseline screening.
Secondary	x-ray dose	average glandular dose receive by women during first level test	This outcome is measured at the baseline screening.
Secondary	reading time	time needed to read an imaging first level examination	This outcome is measured at the baseline screening.