NCT03587259

Brief Summary

The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice. It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

June 27, 2018

Last Update Submit

July 13, 2018

Conditions

Breast Cancer

Keywords

breast cancer screeningtomosynthesisdigital mammography

Outcome Measures

Primary Outcomes (1)

  • the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +)

    number of T2+ screen-detected cancers divided by all screened women at subsequent round of screening and number of T2+ interval cancers divided by all screened women at subsequent round of screening.

    three years

Secondary Outcomes (4)

  • recall rate

    two years

  • detection rate

    two years

  • benign biopsies rate

    two years

  • cost analysis

    two years

Study Arms (2)

2D mammography

ACTIVE COMPARATOR

45-46 years old women are invited to attend the usual screening examination (2D mammography). The next year they will be invited to make a 2D mammography, according to screening protocol.

Diagnostic Test: 2D mammography

Tomosynthesis

EXPERIMENTAL

45-46 years old women are invited to attend the Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM). The next year they will be invited to make a 2D mammography, according to screening protocol.

Diagnostic Test: Tomosynthesis

Interventions

TomosynthesisDIAGNOSTIC_TEST

DBT is a x-ray examination that allows to visualize the breast on 3 planes (3D) and therefore to help to see lesions hardly visible to mammography due to the overlap of glandular tissue.

Also known as: Digital Breast Tomosynthesis (DBT)
Tomosynthesis
2D mammographyDIAGNOSTIC_TEST

2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.

2D mammography

Eligibility Criteria

Age45 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old women resident in the screening area

You may not qualify if:

  • previous breast cancer
  • written refusal to participate in the screening programme
  • pregnancy, breastfeeding
  • presence of prostheses;
  • ongoing chemotherapy;
  • impossibility to submit the informed consent for linguistic problems or for inability of women to provide informed consent;
  • verified presence of BRCA1 - BRCA2 (Breast Related Cancer Antigens 1 - Breast Related Cancer Antigens 2) genetic mutation or involvement in surveillance path for heredo-familial tumor;
  • previous known tomosynthesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South-Est Local Health Unit

Arezzo, 52100, Italy

Location

Oncological Network, Prevention and Research Institute

Florence, 50139, Italy

Location

Related Publications (10)

  • Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fanto C, Valentini M, Montemezzi S, Macaskill P. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25.

    PMID: 23623721BACKGROUND

  • Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.

    PMID: 23297332BACKGROUND

  • Gilbert FJ, Tucker L, Gillan MG, Willsher P, Cooke J, Duncan KA, Michell MJ, Dobson HM, Lim YY, Purushothaman H, Strudley C, Astley SM, Morrish O, Young KC, Duffy SW. The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone. Health Technol Assess. 2015 Jan;19(4):i-xxv, 1-136. doi: 10.3310/hta19040.

    PMID: 25599513BACKGROUND

  • Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24.

    PMID: 24484063BACKGROUND

  • Paci E, Mantellini P, Giorgi Rossi P, Falini P, Puliti D; TBST Working Group. [Tailored Breast Screening Trial (TBST)]. Epidemiol Prev. 2013 Jul-Oct;37(4-5):317-27. Italian.

    PMID: 24293498BACKGROUND

  • McDonald ES, McCarthy AM, Akhtar AL, Synnestvedt MB, Schnall M, Conant EF. Baseline Screening Mammography: Performance of Full-Field Digital Mammography Versus Digital Breast Tomosynthesis. AJR Am J Roentgenol. 2015 Nov;205(5):1143-8. doi: 10.2214/AJR.15.14406.

    PMID: 26496565BACKGROUND

  • Bernardi D, Ciatto S, Pellegrini M, Anesi V, Burlon S, Cauli E, Depaoli M, Larentis L, Malesani V, Targa L, Baldo P, Houssami N. Application of breast tomosynthesis in screening: incremental effect on mammography acquisition and reading time. Br J Radiol. 2012 Dec;85(1020):e1174-8. doi: 10.1259/bjr/19385909.

    PMID: 23175484BACKGROUND

  • Bernardi D, Belli P, Benelli E, Brancato B, Bucchi L, Calabrese M, Carbonaro LA, Caumo F, Cavallo-Marincola B, Clauser P, Fedato C, Frigerio A, Galli V, Giordano L, Giorgi Rossi P, Golinelli P, Morrone D, Mariscotti G, Martincich L, Montemezzi S, Naldoni C, Paduos A, Panizza P, Pediconi F, Querci F, Rizzo A, Saguatti G, Tagliafico A, Trimboli RM, Zappa M, Zuiani C, Sardanelli F. Digital breast tomosynthesis (DBT): recommendations from the Italian College of Breast Radiologists (ICBR) by the Italian Society of Medical Radiology (SIRM) and the Italian Group for Mammography Screening (GISMa). Radiol Med. 2017 Oct;122(10):723-730. doi: 10.1007/s11547-017-0769-z. Epub 2017 May 25.

    PMID: 28540564BACKGROUND

  • Lang K, Andersson I, Rosso A, Tingberg A, Timberg P, Zackrisson S. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmo Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2016 Jan;26(1):184-90. doi: 10.1007/s00330-015-3803-3. Epub 2015 May 1.

    PMID: 25929946BACKGROUND

  • Lang K, Nergarden M, Andersson I, Rosso A, Zackrisson S. False positives in breast cancer screening with one-view breast tomosynthesis: An analysis of findings leading to recall, work-up and biopsy rates in the Malmo Breast Tomosynthesis Screening Trial. Eur Radiol. 2016 Nov;26(11):3899-3907. doi: 10.1007/s00330-016-4265-y. Epub 2016 Mar 4.

    PMID: 26943342BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Paola Mantellini, MDr

    Oncological Network, Prevention and Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Mantellini, MDr

CONTACT

05532697961p.mantellini@ispro.toscana.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 16, 2018

Study Start

September 3, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations

IT(2)