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Screening for Breast Cancer With Digital Breast Tomosynthesis

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Digital Breast Tomosynthesis

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Tomosynthesis,sensitivity,specificity,screening,mammography

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Azienda Sanitaria Locale Reggio EmiliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital Breast Tomosynthesis

standard mammography

Arm Description

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

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

Outcomes

Primary Outcome Measures

cumulative incidence of T2+ cancers after screening

incidence of interval cancers

Secondary Outcome Measures

Detection rate

recall rate

Positive Predictive value

diagnostic agreement between tomosynthesis and 2d mammography

Detection rate of in situ ductal carcinoma

biopsy rate

self-reported pain and discomfort during mammography

x-ray dose

Full Information

NCT ID

NCT02698202

First Posted

February 26, 2016

Last Updated

March 3, 2016

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

Collaborators

Arcispedale Santa Maria Nuova-IRCCS, Regione Emilia-Romagna

1. Study Identification

Unique Protocol Identification Number

NCT02698202

Brief Title

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

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

Collaborators

Arcispedale Santa Maria Nuova-IRCCS, Regione Emilia-Romagna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Tomosynthesis,sensitivity,specificity,screening,mammography

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Digital Breast Tomosynthesis

Arm Type

Experimental

Arm Description

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

Arm Title

standard mammography

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Digital Breast Tomosynthesis

Intervention Description

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

Primary Outcome Measure Information:

Title

cumulative incidence of T2+ cancers after screening

Time Frame

2 years

Title

incidence of interval cancers

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Detection rate

Time Frame

2 years

Title

recall rate

Time Frame

baseline

Title

Positive Predictive value

Time Frame

baseline

Title

diagnostic agreement between tomosynthesis and 2d mammography

Time Frame

baseline

Title

Detection rate of in situ ductal carcinoma

Time Frame

2 years

Title

biopsy rate

Time Frame

baseline

Title

self-reported pain and discomfort during mammography

Time Frame

baseline

Title

x-ray dose

Time Frame

baseline

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierpaolo Pattacini, MD

Phone

+390522296369

Pierpaolo.Pattacini@asmn.re.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierpaolo Pattacini, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda Sanitaria Locale Reggio Emilia

City

Reggio Emilia

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luisa Paterlini

12. IPD Sharing Statement

Citations:

PubMed Identifier

35103537

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.

Results Reference

derived

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Screening for Breast Cancer With Digital Breast Tomosynthesis

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