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Screening for Breast Cancer With Digital Breast Tomosynthesis

NCT ID: NCT02698202

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26877 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-10

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Tomosynthesis,sensitivity,specificity,screening,mammography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Study Groups

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Digital Breast Tomosynthesis

to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

Group Type EXPERIMENTAL

Digital Breast Tomosynthesis

Intervention Type DEVICE

twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

standard mammography

to the control arm the usual 2D standard mammography exam will be offered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Breast Tomosynthesis

twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regione Emilia-Romagna

OTHER

Sponsor Role collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierpaolo Pattacini, MD

Role: PRINCIPAL_INVESTIGATOR

Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy

Locations

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Azienda Sanitaria Locale Reggio Emilia

Reggio Emilia, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 35103537 (View on PubMed)

Other Identifiers

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ReTomo

Identifier Type: -

Identifier Source: org_study_id