Clinical trial NCT02698202: Screening for Breast Cancer With Digital Breast Tomosynthesis
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Tomosynthesis,sensitivity,specificity,screening,mammography
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: Regione Emilia-Romagna
First posted: 2016-03-03
Enrollment: 40000
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Detailed description: The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).

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

Eligibility criteria: Inclusion Criteria:

45-70 years old women invited to breast cancer screening program who accepted to participate

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

Primary outcomes:
measure: cumulative incidence of T2+ cancers after screening
timeFrame: 2 years
measure: incidence of interval cancers
timeFrame: 2 years
Secondary outcomes:
measure: Detection rate
timeFrame: 2 years
measure: recall rate
timeFrame: baseline
measure: Positive Predictive value
timeFrame: baseline
measure: diagnostic agreement between tomosynthesis and 2d mammography
timeFrame: baseline
measure: Detection rate of in situ ductal carcinoma
timeFrame: 2 years
measure: biopsy rate
timeFrame: baseline
measure: self-reported pain and discomfort during mammography
timeFrame: baseline
measure: x-ray dose
timeFrame: baseline
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda Sanitaria Locale Reggio Emilia
Study officials:
affiliation: Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy
name: Pierpaolo Pattacini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1.